FDA Device recall Z-1310-2022
TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
- FDA Device
- Class II
- terminated
- Published 2022-07-06
On 2022-07-06 the FDA classified a Class II recall of TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034 by Haemonetics, citing due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comp….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1310-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-04-26 |
| Published | 2022-07-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Haemonetics |
| Distribution | US |
Product
TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Reason
Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to the normal donor reference range, it could lead to misdiagnosis and incorrect treatment or failure to treat.
Identifiers
| code_info | UDI-DI: (01)20812747018095 All lots are affected. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1310-2022%22
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