Recall Z-1310-2022 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Haemonetics Corporation
TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
| Date | Apr 26, 2022 |
| Status | Terminated |
| 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. |
| Root cause | Other |
| Action | On April 26, 2022, affected customers were provided with a recall letter via email. Customers may continue to use the TEG 5000 Functional Fibrinogen reagent with the current IFU in conjunction with the letter which reflects the updated ranges. Haemonetics will provide a revision to the IFU. Additionally, customers using Functional Fibrinogen reagent are being reminded to continue to follow the instructions in the current Instructions for Use (118474-MULTI (XX)), which state - Results from the TEG analyzer should not be the sole basis for a patient diagnosis TEG analyzer results should be con |
| Quantity | 3933 kits (US); 2429 kits (OUS) |
| Distribution | Domestic distribution US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002177 | THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES Haemoscope Corp., Sep 14, 2000 |