FDAFDA recall Z-0001-2027 · Oct 21, 2026
Instrumentation Laboratory: HemoslL AcuStar HIT-lgG(PF-4) recall
Recall found
Product
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic
Reason for recall
Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class I: FDA's most serious class, where use of or exposure to the product may cause serious health problems or death.
- Status
- Ongoing
- Codes, lots and dates
- Part Number: 0009800127. UDI-DI: 08426951126545. Lot Number (Expiration Date): B40005 (01/16/2027), B38062 (11/01/2026).
- Quantity
- 434 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.
- Recalling firm
- Instrumentation Laboratory, Bedford, MA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-09-03
Source: openFDA enforcement record Z-0001-2027 · search recall number Z-0001-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 26, 2026, 8:14 PM EDT. The agency notice is the final word.