Z-1310-2022Class II

TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034

Name: Z-1310-2022 TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Creator: Haemonetics Corporation
Published: 2022-04-26
License: https://open.fda.gov/license/

Haemonetics Corporation / initiated 2022-04-26 / Terminated / root cause: labeling and UDI

FDA source

Haemonetics Corporation began a recall of TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034 on 2022-04-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1310-2022
Classification: Class II
Status: Terminated
Initiated: 2022-04-26
Posted: 2022-06-30
Terminated: 2024-03-15
Recalling firm: Haemonetics Corporation
Product: TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 3933 kits (US); 2429 kits (OUS)
Distribution: Domestic distribution US Nationwide.
Product codes and lots: UDI-DI: (01)20812747018095 All lots are affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1310-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1310-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-06	2022-06-30

Product code JPA

K002177Class IIThrombelastograph Coagulation Analyzer Teg-5000 SeriesHaemoscope Corp. / cleared 2000-09-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)