FDA-Device2026-10-21Class IPROCESSING DEFECT
Instrumentation Laboratory HemosIL AcuStar HIT-IgG(PF-4) recalled for invalid calibration and measurement bias
What this means
Instrumentation Laboratory's HemosIL AcuStar HIT-IgG(PF-4) laboratory test kit may produce invalid calibration curves or inaccurate results with up to 47% negative bias in patient samples. This affects 1,414 units distributed worldwide, including specific U.S. states and multiple countries.
- Check if your laboratory uses the affected lot numbers B40006 (expires 01/16/2027) or B38063 (expires 11/01/2026) with part number 0009802028.
- Contact Instrumentation Laboratory for guidance on affected units and next steps.
- Do not use affected kits until you receive instructions from the manufacturer or your laboratory director.
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
1,414 units
Manufactured in
180 Hartwell Rd, Bedford, MA, United States
Products
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0002-2027More Instrumentation Laboratory recalls
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.