Instrumentation Laboratory: Platelet Factor 4 Radioimmunoassay
- Recalling firm
- Instrumentation Laboratory
- Product
- HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic
- 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/c359925c-74f8-4009-8614-08f642a54d1b