HemoslL AcuStar HIT-lgG recall (Instrumentation Laboratory)
Medical deviceClass IOngoing
Summary: Instrumentation Laboratory is recalling HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic. Reason: Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
What is being recalled
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic
Why
Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
How serious is it
Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.
Where it was sold
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. (states named: Arkansas, Arizona, California, Connecticut, Florida, Georgia, Massachusetts, Maryland, New Jersey, New York, Pennsylvania, Rhode Island, Tennessee, Washington, West Virginia)
How to tell if yours is affected
Part Number: 0009800127. UDI-DI: 08426951126545. Lot Number (Expiration Date): B40005 (01/16/2027), B38062 (11/01/2026).
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0001-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class I |
| Status | Ongoing |
| Recall started | September 3, 2026 |
| Reported | October 21, 2026 |
| Company | Instrumentation Laboratory |
| Company location | Bedford, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 434 units |
More recalls from Instrumentation Laboratory · all medical device recalls · recalls from September 2026