FDA Device recall Z-0276-2022
HemosIL ReadiPlasTin (20 mL), Part number 0020301400
- FDA Device
- Class II
- ongoing
- Published 2021-12-01
On 2021-12-01 the FDA classified a Class II recall of HemosIL ReadiPlasTin (20 mL), Part number 0020301400 by Instrumentation Laboratory, citing the firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. I….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0276-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-10-13 |
| Published | 2021-12-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Instrumentation Laboratory |
| Distribution | US |
Product
HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
Reason
The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or do not pass for each vial of reagent, there is a potential risk of reporting an erroneous result.
Identifiers
| code_info | Lot N0705526 UDI: 08426950632887 ***Updated 3/3/22*** Firm has expanded recall to include the following lot: N0806224 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0276-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.