Device recall
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
- Recall number
- Z-0002-2027
- Event id
- 99843
- Status
- Ongoing
- FDA classification
- Class I
- Recalling firm
- Instrumentation Laboratory
- Report date
- Oct 21, 2026
- Posted
- Oct 10, 2026
- Initiated
- Sep 3, 2026
- Center classification date
- Oct 9, 2026
- Product code
- LCO
- Device type
- Platelet Factor 4 Radioimmunoassay
- Reason
- Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
- Root cause
- Under Investigation by firm
- Quantity
- 1,414 units
- Code info
- Part Number: 0009802028. UDI-DI: 08426950545774. Lot Number (Expiration Date): B40006 (01/16/2027), B38063 (11/01/2026).
- 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 Korea, Luxembourg, Latvia, Netherlands, Saudi Arabia, Sweden, Singapore.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K170854
- Location
- Bedford, MA, United States