Instrumentation Laboratory Co.
Complete recall history across all FDA and CPSC categories — 31 total recalls
Instrumentation Laboratory Co. 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 (31)
FDA medical device enforcement actions by Instrumentation Laboratory Co.
| Date | Product | Reason | Class |
|---|---|---|---|
| Jul 23, 2019 | ROTEM ex-tem; US Part No: 503-05-US | Prolonged clotting times | Class II |
| Jul 23, 2019 | ROTEM ex-tem Rest of the world part No: 503-05 (ROW) | Prolonged clotting times | Class II |
| Jul 23, 2019 | ROTEM ex-tem Canada Part No: 503-05-CA | Prolonged clotting times | Class II |
| Aug 1, 2018 | Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - ... | There is a potential for increased imprecision, out of range quality controls... | Class II |
| Aug 2, 2017 | Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400 | Instrumentation Laboratory Co. received customer reports of performance issue... | Class II |
| Dec 18, 2015 | HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Co... | This Lot is not meeting labeled on-board instrument stability claims of 5 days. | Class II |
| Nov 21, 2014 | HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company.... | Some vials of HemosIL PT-Fibrinogen HS PLUS, Part No. 0008469810 (various lo... | Class II |
| Jun 3, 2014 | ACL TOP CTS, automated coagulation laboratory instrument. | Potential for sample misidentification. | Class II |
| Jun 3, 2014 | ACL TOP 300 CTS, automated coagulation laboratory instrument. | Potential for sample misidentification. | Class II |
| Jun 3, 2014 | ACL TOP 700 CTS, automated coagulation laboratory instrument. | Potential for sample misidentification. | Class II |
| Jun 3, 2014 | ACL TOP 700 LAS, automated coagulation laboratory instrument. | Potential for sample misidentification. | Class II |
| Jun 3, 2014 | ACL TOP 700, automated coagulation laboratory instrument. | Potential for sample misidentification. | Class II |
| Jun 3, 2014 | ACL TOP (Base), automated coagulation laboratory instrument. | Potential for sample misidentification. | Class II |
| Jun 3, 2014 | ACL TOP 500 CTS, automated coagulation laboratory instrument. | Potential for sample misidentification. | Class II |
| Nov 15, 2013 | HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220 | HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 51... | Class II |
| Nov 15, 2013 | HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120 | HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 51... | Class II |
| Nov 15, 2013 | HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320 | HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 51... | Class II |
| Jul 19, 2013 | ACL TOP 700 LAS; PN 0000280030 Bench top, fully automated, random access a... | Potential carryover issue that can can cause shortened APTT clotting times on... | Class II |
| Jul 19, 2013 | ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access a... | Potential carryover issue that can can cause shortened APTT clotting times on... | Class II |
| Jul 19, 2013 | ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 Bench top, fully au... | Potential carryover issue that can can cause shortened APTT clotting times on... | Class II |
| Jul 19, 2013 | ACL TOP 700 CTS; PN 0000280050 Bench top, fully automated, random access a... | Potential carryover issue that can can cause shortened APTT clotting times on... | Class II |
| Jul 19, 2013 | ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analy... | Potential carryover issue that can can cause shortened APTT clotting times on... | Class II |
| Jul 19, 2013 | ACL TOP 700; PN 0000280010 Bench top, fully automated, random access analy... | Potential carryover issue that can can cause shortened APTT clotting times on... | Class II |
| Jul 19, 2013 | ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access an... | Potential carryover issue that can can cause shortened APTT clotting times on... | Class II |
| Apr 9, 2013 | HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is... | Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Pa... | Class II |
| Aug 3, 2012 | Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a b... | Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample R... | Class II |
| Aug 3, 2012 | Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench t... | Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample R... | Class II |
| Aug 3, 2012 | Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a b... | Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample R... | Class II |
| Aug 3, 2012 | Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench ... | Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample R... | Class II |
| Aug 3, 2012 | Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a b... | Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample R... | Class II |
| Aug 3, 2012 | Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a benc... | Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample R... | 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.
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