Class IDeviceOngoing

Instrumentation Laboratory

HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)

Reason for recall

Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.

Details

Recall number: Z-0002-2027
Event ID: 99843
Recall initiated: Sep 3, 2026
Classified: Oct 9, 2026
Reported: Oct 21, 2026
Quantity: 1,414 units
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.
Initiated by: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Firm location: Bedford, MA, United States
Lot / code info: Part Number: 0009802028. UDI-DI: 08426950545774. Lot Number (Expiration Date): B40006 (01/16/2027), B38063 (11/01/2026).