Instrumentation Laboratory: Platelet Factor 4 Radioimmunoassay
Recall Summary Instrumentation Laboratory is recalling the HemoslL AcuStar HIT-lgG(PF-4) blood test kit (Part Number: 0009802028) used to detect a specific blood clotting condition. The test may produce inaccurate results due to calibration problems that could underestimate patient values by up to 47%. The product was distributed nationwide in the U.S. and in multiple countries internationally.
- Recalling firm
- Instrumentation Laboratory
- Product
- HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
- Reason
- Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-09-03
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, FL, GA, MA, MD, NJ, NY, PA, RI, TN, WA, WV and the countries of Austria, Belgium, Switzerland, Costa Rica, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, India, Italy, Jordan, Japan, South...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/f2c9c838-e3ed-471a-8726-d887fdf0c823