FDA Medical Device Recalls (openFDA)
Haemonetics Corporation: TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
- Recall number
- Z-1310-2022
- Recalling firm
- Haemonetics Corporation
- Product
- TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
- Status
- Terminated
- Initiated
- 2022-04-26
- Posted
- not on file
- Terminated
- 2024-03-15
- 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 considered along with a clinical assessment of the patient's condition and other coagulation laboratory tests.
- Quantity
- 3933 kits (US); 2429 kits (OUS)
- Distribution
- Domestic distribution US Nationwide.
- Lot, serial or model codes
- UDI-DI: (01)20812747018095 All lots are affected.
- 510(k) numbers
- ["K002177"]
- PMA numbers
- not on file
- Product code
- JPA
- Firm FEI
- 1219343
- Firm city
- Boston
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28