Cell Marque Corporation

Complete recall history across all FDA and CPSC categories — 16 total recalls

Cell Marque Corporation 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 (16)

FDA medical device enforcement actions by Cell Marque Corporation

Date Product Reason Class
Jul 15, 2021 Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15,... Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 20... Class III
May 27, 2021 Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, R... Product distributed for use as an In-vitro Diagnostics without FDA clearance Class II
May 27, 2021 Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, I... Product distributed for use as an In-vitro Diagnostics without FDA clearance Class II
May 5, 2017 Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagn... Cell Marque has determined the need to issue a product recall after identifyi... Class II
May 5, 2017 Estrogen Receptor (EP1) 7.0 mL Catalog number 249R-28; 1.0 mL Catalog num... Cell Marque has determined the need to issue a product recall after identifyi... Class II
May 5, 2017 SV40 (MRQ-4) 0.5 ml catalog number 351 M-15. Microbiology - Analyte Spec... Cell Marque has determined the need to issue a product recall after identifyi... Class II
May 5, 2017 Estrogen Receptor (SP1) 7.0 mL Catalog number 249R-18; Hematology - Anal... Cell Marque has determined the need to issue a product recall after identifyi... Class II
May 5, 2017 CD117, c-kit (YR145) 1.0 ml catalog number 117R-16 7.0 ml catalog number-18... Cell Marque has determined the need to issue a product recall after identifyi... Class II
May 5, 2017 Adenovirus (20/11 & 2/6); 0.5 mL Catalog # 212M-15; and 7.0 mL Catalog nu... Cell Marque has determined the need to issue a product recall after identifyi... Class II
May 5, 2017 Herpes Simplex Virus II 0.5 ml catalog number 362A-15 7.0 mL Catalog number... Cell Marque has determined the need to issue a product recall after identifyi... Class II
May 5, 2017 Her2/Neu (EP3); 0.5 mL Catalog number 237R-25; 1.0 mL Catalog number 237R-2... Cell Marque has determined the need to issue a product recall after identifyi... Class II
May 5, 2017 Herpes Simplex Virus I; 7.0 mL Catalog number 361A-18. Microbiology - Ana... Cell Marque has determined the need to issue a product recall after identifyi... Class II
May 5, 2017 Varicella Zoster Virus 7.0 ml catalog number 364M-18 Microbiology - Analy... Cell Marque has determined the need to issue a product recall after identifyi... Class II
May 5, 2017 H. pylori (polyclonal} 1.0 mL Catalog number 215A-76; Hematology - Analyt... Cell Marque has determined the need to issue a product recall after identifyi... Class II
May 5, 2017 HHV-8 (13810); 1.0 ml catalog number 265M-16; 7.0 ml catalog number-265M-18... Cell Marque has determined the need to issue a product recall after identifyi... Class II
May 10, 2016 SIOOA I (EP I84) Rabbit Monoclonal Antibody; Catalogue numbers 408R-14, 408R... Cell Marque became aware of some lots of SIOOA I (EP I84) Rabbit Monoclonal A... Class II

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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