Z-1298-2022Class II

Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG...

Name: Z-1298-2022 Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG...
Creator: Haemonetics Corporation
Published: 2022-04-19
License: https://open.fda.gov/license/

Haemonetics Corporation / initiated 2022-04-19 / Terminated / root cause: software

FDA source

Haemonetics Corporation began a recall of Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay - PlateletMapping ADP & AA... on 2022-04-19. FDA classified it as Class II and gives the reason as "When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect values of the PlateletMapping ADP or AA % Inhibition and % Aggretagion...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1298-2022
Classification: Class II
Status: Terminated
Initiated: 2022-04-19
Posted: 2022-06-28
Terminated: 2024-03-27
Recalling firm: Haemonetics Corporation
Product: Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay - PlateletMapping ADP & AA (07-014), PlateletMapping ADP (07-015), PlateletMapping AA (07-016). Issue occurs when Platelet Mapping Assay results from a TEG 5000 analyzer are viewed using TEG Manager Software (versions 1.1-4.3.1)
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
Reason for recall: When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect values of the PlateletMapping ADP or AA % Inhibition and % Aggretagion may be displayed on TEG Manager for the affected assays.
Root cause tag: software
FDA root cause: Software design
Action: On April 22, 2022, the firm notified affected customers of the recall via email. Customers were asked to complete and return the attached acknowledgement form. Upon receipt, Haemonetics will contact the customer to arrange the remote installation of the updated software, version 4.4.0, which will resolve the issue.
Quantity in commerce: 111
Distribution: US Nationwide.
Product codes and lots: This correction is applicable when TEG 5000 PlateletMapping (Item # 07-014, 07-015, 07-016) is performed on a TEG 5000 analyzer (Item # 07-022, 07-033) that is connected to TEG Manager Software which includes viewing of TEG 5000 results. Code Info: UDI-DI: (01)30812747018184 Software Version: TEGM 1.1 and later, TAS v4.2.3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1298-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1298-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-06	2022-06-28

Product code JPA

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)