HemoslL AcuStar HIT-lgG (Z-0002-2027) Recall
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was HemoslL AcuStar HIT-lgG recalled?
Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
Which lot codes, UPCs or models are affected?
Part Number: 0009802028. UDI-DI: 08426950545774. Lot Number (Expiration Date): B40006 (01/16/2027), B38063 (11/01/2026).
- Agency record number
- Z-0002-2027
- Product
- HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
- Recalling firm
- Instrumentation Laboratory
- 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.
- Recall started
- September 3, 2026
- Report date
- October 21, 2026
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)