Remel Inc

Complete recall history across all FDA and CPSC categories — 70 total recalls

Remel Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (70)

FDA medical device enforcement actions by Remel Inc. Showing most recent 50.

Date Product Reason Class
Oct 20, 2022 Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST An internal technical investigation has confirmed that Thermo Scientific" Gra... Class I
Oct 20, 2022 Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST An internal technical investigation has confirmed that Thermo Scientific" Gra... Class I
Oct 20, 2022 Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST An internal technical investigation has confirmed that Thermo Scientific" Gra... Class I
Oct 20, 2022 Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST An internal technical investigation has confirmed that Thermo Scientific" Gra... Class I
Oct 20, 2022 Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST An internal technical investigation has confirmed that Thermo Scientific" Gra... Class I
Oct 20, 2022 Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST An internal technical investigation has confirmed that Thermo Scientific" Gra... Class I
Oct 20, 2022 Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST An internal technical investigation has confirmed that Thermo Scientific" Gra... Class I
Oct 20, 2022 Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST An internal technical investigation has confirmed that Thermo Scientific" Gra... Class I
Oct 20, 2022 Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST An internal technical investigation has confirmed that Thermo Scientific" Gra... Class I
Jan 10, 2022 Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD ... There are lower than expected MICs for some gram negative species. Class II
Jun 18, 2021 ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the... Out of Specification Class II
Apr 22, 2021 Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/pack... The media allows growth of E. faecalis ATCC 29212 with blackening of the media. Class II
Mar 10, 2021 Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus ... When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may ex... Class II
Mar 10, 2021 Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus... When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may ex... Class II
Dec 10, 2020 Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049 The blood agar side of the bi-plate may not grow some patient isolates or QC ... Class II
Apr 17, 2019 Thio Med w/Dex, Hem, Vit K (9ml) 100/PK Product Usage: Recommended for us... Potential for products to fail performance testing per the Instructions for U... Class II
Apr 17, 2019 Thio Med w/Dex, Hem, Vit K (10ml) 20/PK Product Usage: Recommended for us... Potential for products to fail performance testing per the Instructions for U... Class II
Apr 17, 2019 Thio Med w/o Ind, w/Dex (9ml) 100/PK Product Usage: Recommended for use i... Potential for products to fail performance testing per the Instructions for U... Class II
Apr 17, 2019 Thio Med w/Dex, Hem, Vit K (9ml) 20/PK Product Usage: Recommended for use... Potential for products to fail performance testing per the Instructions for U... Class II
Apr 17, 2019 Thio Med w/o Ind, w/Dex (18ml) 100/PK Product Usage: Recommended for use ... Potential for products to fail performance testing per the Instructions for U... Class II
Apr 17, 2019 Thio Med w/Dex, Hem, Vit K (7ml) 20/PK Product Usage; Recommended for u... Potential for products to fail performance testing per the Instructions for U... Class II
Apr 17, 2019 Thio Med w/o Ind, w/Dex (9ml) 20/PK Product Usage: Recommended for use in... Potential for products to fail performance testing per the Instructions for U... Class II
Apr 17, 2019 Thio Med w/Dex, Hem, Vit K(10ml) 100/PK Product Usage: Recommended for us... Potential for products to fail performance testing per the Instructions for U... Class II
Apr 17, 2019 Thio Med w/Dex, Hem, Vit, K (7ml) 100/PK Product Usage; Recommended for... Potential for products to fail performance testing per the Instructions for U... Class II
Apr 17, 2019 Thio Med w/Dex, Hemin, Vit K (5ml) 20/PK Product Usage: Recommended for u... Potential for products to fail performance testing per the Instructions for U... Class II
Apr 17, 2019 Thio Med w/o Ind, w/Dex (10ml) 100/PK Product Usage: Recommended for use ... Potential for products to fail performance testing per the Instructions for U... Class II
Apr 17, 2019 Thio Med w/o Ind, w/Dex (10ml) 20/PK Product Usage: Recommended for use i... Potential for products to fail performance testing per the Instructions for U... Class II
Apr 17, 2019 Thio Med w/o Ind, w/Dex (18ml) 20/PK Product Usage: Recommended for use i... Potential for products to fail performance testing per the Instructions for U... Class II
Apr 17, 2019 Thio Med w/Dex, Hem, Vit K (5ml) 100/PK Product Usage; Recommended for ... Potential for products to fail performance testing per the Instructions for U... Class II
Aug 13, 2018 remel THIOGLYCOLLATE MEDIUM W/O IND. W/ DEXTROSE W/ HEMIN & VIT.K (a) 10ML, ... Products have intermittently failed performance testing during stability stud... Class II
Aug 13, 2018 remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML, REF 064700 ... Products have intermittently failed performance testing during stability stud... Class II
Aug 13, 2018 remel THIOGLYCOLLATE MEDIUM, REF 05152 Products have intermittently failed performance testing during stability stud... Class II
Dec 8, 2017 Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01. ... The serum may fail to agglutinate within the specified minimum reaction time. Class II
Nov 2, 2017 CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres. Product may have incorrect cation information detailed on the product label. Class II
Mar 24, 2017 Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel,... Confirmed complaint of surface contamination of Listeria monocytogenes. Class II
Feb 9, 2017 Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm ... Test organisms exhibit poor growth when grown using the test agar. The poor g... Class II
Mar 24, 2016 Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For... Individual bottles of product may produce weak beta-lactamase reactions. Use... Class II
Nov 6, 2015 Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT002... Antibiotic concentration may be insufficient which may result in incorrect te... Class II
Jun 30, 2015 PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper b... A reagent present may produce weak or slow reactions; continued use may resul... Class II
Jun 30, 2015 PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex ... A reagent present may produce weak or slow reactions; continued use may resul... Class II
May 19, 2015 VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The ... Use of the recalled product may result in false positive reports. Class II
May 19, 2015 VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The ... Use of the recalled product may result in false positive reports. Class II
May 4, 2015 Remel Blood Agar (TSA w/sheep blood) plate REF R01202 packaged 10 plates per ... Product may be contaminated with Listeria monocytogenes. Class II
Feb 5, 2015 Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ... Use of the product may not provide adequate recovery and could result in fals... Class II
Nov 13, 2014 Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. ... Use of the product could result in inadequate recovery of Legionella pneumoph... Class II
Oct 29, 2014 Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottl... The product may appear cloudy or discolored and may not perform correctly in ... Class II
Oct 23, 2014 Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests ... A reagent within the test may return false negative results. Class II
Oct 23, 2014 Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box co... A reagent within the test may return false negative results. Class II
Oct 17, 2014 Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10... Recalled product may not provide adequate recovery of Legionella pneumophila ... Class II
Jun 11, 2014 Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aero... Bottles did not provide positive signals within the time frame of the quality... Class II

View all 70 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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