Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 29352 |
| Brand Name: | Haemonetics Braintree Fundtional Fribrinogen Reagent |
| Model: | TEG 5000 (07-034) |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Haemonetics New Zealand Limited No 120, 300 Richmond Road Grey Lynn Auckland 1021 |
| Contact Information: | |
| Manufacturer: | Haemonetics Corporation |
| Issue: | The product instructions for use (118474-MULTI) is being updated to revise the Citrated Blood Reference Range for the maximum amplitude (CFF-MA) and the functional fibrinogen level (FLEV). If the clinician relies solely on these TEG 5000 results in comparison to the normal donor reference range, it could lead to misdiagnosis and incorrect treatment or failure to treat. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 9/5/2022 |
