HemoslL AcuStar HIT-lgG(PF-4) Test Kit May Have Calibration Errors
Instrumentation Laboratory recalls 1,414 HemoslL AcuStar HIT-lgG(PF-4) test kits with part number 0009802028 due to potential calibration errors. Affected units sold worldwide in 2026.
Use caution until it’s fixed
Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
What happened, in plain English
Instrumentation Laboratory is recalling 1,414 units of HemoslL AcuStar HIT-lgG(PF-4) test kits because they may produce inaccurate results. This could lead to incorrect patient diagnoses if used with patient samples. Read more at govinfonow.com/recall/1764697-instrumentation-laboratory-recalls-hemosll-acustar-hit-lgg-pf-4-part.
Source Summary by GovInfoNow · govinfonow.com/recall/1764697-instrumentation-laboratory-recalls-hemosll-acustar-hit-lgg-pf-4-part · Published October 27, 2026 · Updated October 27, 2026 · FDA enforcement record: FDA #Z-0002-2027
Cite this page
“HemoslL AcuStar HIT-lgG(PF-4) Test Kit May Have Calibration Errors.” GovInfoNow, updated October 27, 2026. https://govinfonow.com/recall/1764697-instrumentation-laboratory-recalls-hemosll-acustar-hit-lgg-pf-4-part. Based on FDA recall #Z-0002-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0002-2027%22&limit=1).
Why it’s dangerous
The test kits may show a negative mean bias of up to 47% with patient samples, meaning results could be significantly inaccurate. This could lead to incorrect diagnoses if the test is used with patient blood samples.
Who’s affected
Healthcare professionals using the test kits in labs or clinics are most at risk. Patients relying on these tests for diagnosis could receive incorrect results.
How to tell if you have this one
Check for part number 0009802028 on the test kit. Affected units have lot numbers B40006 (expiring 01/16/2027) or B38063 (expiring 11/01/2026).
- Brand
Instrumentation Laboratory- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Ongoing- 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 number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0001-2027 | HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic; Part Number: 0009800127. UDI-DI: 08426951126545. Lot Number (Expiration Date): B40005 (01/16/2027), B38062 (11/01/2026). | 434 units |
| Z-0002-2027 | HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only); Part Number: 0009802028. UDI-DI: 08426950545774. Lot Number (Expiration Date): B40006 (01/16/2027), B38063 (11/01/2026). | 1,414 units |
What to do — step by step
Check Product Details
Look for part number 0009802028 and lot numbers B40006 (expiring 01/16/2027) or B38063 (expiring 11/01/2026) on the test kit.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 15 states.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Arkansas, California, Connecticut, Florida, Georgia, Maryland, Massachusetts, New Jersey, New York, Pennsylvania, Rhode Island, Tennessee, Washington, West Virginia.
Recall timeline
FDA published this recall 48 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
Questions people ask
Where were these test kits sold?
Sold worldwide, including the United States and many other countries.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0002-2027 (September 3, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0002-2027 to see it in context.
- Plain-language summary written by qwen3:4b on October 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.