CLASS I ONGOING Device recall · Reported 21 Oct 2026 · FDA Enforcement Report
HemoslL AcuStar HIT-lgG(PF-4) recalled by Instrumentation Laboratory
Instrumentation Laboratory is recalling HemoslL AcuStar HIT-lgG(PF-4), distributed nationwide in the US. The recall was initiated on 3 Sep 2026 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0001-2027
- FDA event ID
- 99843
- Recalling firm
- Instrumentation Laboratory, Bedford, MA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 3 Sep 2026
- FDA classified
- 9 Oct 2026
- Reported
- 21 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 3 Sep 2026 | Recall initiated by company | |
| 9 Oct 2026 | Classified by FDA | +36 days |
| 21 Oct 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
Product as listed by the FDA
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic
Where it was distributed
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.
Nationwide ArkansasArizonaCaliforniaConnecticutFloridaGeorgiaMassachusettsMarylandNew JerseyNew YorkPennsylvaniaRhode IslandTennesseeWashingtonWest Virginia
Questions about this recall
Why was it recalled?
Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
Which lots are affected?
Part Number: 0009800127. UDI-DI: 08426951126545. Lot Number (Expiration Date): B40005 (01/16/2027), B38062 (11/01/2026).
Where was it 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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 27 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 99843This product is part of a recall event; the main page for the event is HemoslL AcuStar HIT-lgG(PF-4) recalled by Instrumentation Laboratory.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | HemoslL AcuStar HIT-lgG(PF-4) recalled by Instrumentation Laboratory | Instrumentation Laboratory | Other | Nationwide |
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All 79| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | HemoslL AcuStar HIT-lgG(PF-4) recalled by Instrumentation Laboratory | Instrumentation Laboratory | Other | Nationwide |
| Device | CLASS II | The GEM Premier 7000 with iQM3 is a portable critical care recalled | Instrumentation Laboratory | Device Malfunction | Nationwide |
| Device | CLASS II | GEM Premier 5000 PAK Part Numbers recalled by Instrumentation Laboratory | Instrumentation Laboratory | Device Malfunction | Nationwide |
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| Device | CLASS I | HemoslL AcuStar HIT-lgG(PF-4) recalled by Instrumentation Laboratory | Instrumentation Laboratory | Other | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Chemistry Analyzers: AU w/out ISE recalled | Beckman Coulter | Device Malfunction | Nationwide |