Instrumentation Laboratory recalls HemoslL AcuStar HIT-lgG
- Recalling company
- 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 I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- Sep 3, 2026
- Reported
- Oct 21, 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.
- Status
- Ongoing
- Quantity
- 1,414 units
- Lot / codes
- Part Number: 0009802028. UDI-DI: 08426950545774. Lot Number (Expiration Date): B40006 (01/16/2027), B38063 (11/01/2026).
- Company location
- Bedford, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0002-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0002-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.