FDA Device recall Z-0001-2027
HemoslL AcuStar HIT-lgG(PF-4)
- FDA Device
- Class I
- ongoing
- Published 2026-10-21
On 2026-10-21 the FDA classified a Class I recall of HemoslL AcuStar HIT-lgG(PF-4) by Instrumentation Laboratory, citing potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0001-2027 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-09-03 |
| Published | 2026-10-21 |
| Last updated | 2026-10-27 05:30 UTC |
| Company | Instrumentation Laboratory |
| Distribution | US |
Product
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.
Identifiers
| code_info | Part Number: 0009800127. UDI-DI: 08426951126545. Lot Number (Expiration Date): B40005 (01/16/2027), B38062 (11/01/2026). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-27 05:30 UTC. Current status: ongoing.
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- HemoslL AcuStar HIT-lgG(PF-4)
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All Instrumentation Laboratory recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0001-2027%22
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