Instrumentation Laboratory recalls
9 federal recalls on file, showing the 4 from the last 12 months. We read every CPSC, FDA, USDA and NHTSA notice for Instrumentation Laboratory and put it in plain English.
Recent recalls
HemosIL AcuStar HIT-IgG(PF4) test recalled for potential inaccurate resultsInstrumentation Laboratory is recalling two part numbers of the HemosIL AcuStar HIT-IgG(PF4) in vitro diagnostic test, 1,848 units in total. The test may produce an invalid calibration curve, or patient results may read up to 47% lower than they should. The recall covers US states and countries worldwide. No injuries have been reported.
SeriousFDAOct 21, 20262 products
- Instrumentation Laboratory GEM Premier 5000 PAKs recalled for test errors
Instrumentation Laboratory is recalling 20 GEM PAK cartridges for the GEM Premier 5000 system. Customers reported that the cartridges may show 'Process Control Solution Not Detected' (PCSND) errors during warm-up, sometimes repeatedly, which ejects the cartridge and requires inserting a new one. No injuries have been reported.
ModerateFDAMar 18, 202620 products
- Stop using Instrumentation Laboratory coagulation reagent
Instrumentation Laboratory has recalled a coagulation test reagent (Part Number 0020006800, Lot N1136730) used to evaluate blood clotting and monitor heparin therapy due to potential microbial contamination. The affected lot expires 12/31/2025 and was distributed worldwide including multiple U.S. states and countries. No injuries have been reported to date.
ModerateFDAJan 21, 2026
- Stop using affected HemosIL SynthAFax test lots
Instrumentation Laboratory recalled specific lots of HemosIL SynthAFax Partial Thromboplastin Time tests because they were manufactured with twice the intended amount of preservative. This could affect test accuracy. No injuries have been reported.
ModerateFDADec 24, 2025