FDA-Device2026-10-21Class IPROCESSING DEFECT
Instrumentation Laboratory HemosIL AcuStar HIT-IgG(PF-4) test kit recalled for invalid calibration
What this means
Instrumentation Laboratory's HemosIL AcuStar HIT-IgG(PF-4) blood test kit may produce invalid calibration curves or inaccurate results, with errors as high as 47% in some patient samples. This in vitro diagnostic device is used to detect blood clots caused by heparin-induced thrombocytopenia (HIT). Affected lots were distributed worldwide, including 16 U.S. states.
- If your laboratory uses Part Number 0009800127 (Lot B40005 or B38062), stop using it immediately.
- Contact Instrumentation Laboratory for instructions on device replacement or return.
- Notify your clinical team so they can review any test results from affected lots.
The agency's original wording
Hazard
Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
Intended for
All ages
Illnesses reported
None reported
Sold states
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.
Affected count
434 units
Manufactured in
180 Hartwell Rd, Bedford, MA, United States
Products
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0001-2027More Instrumentation Laboratory recalls
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