Z-1796-2013Class II

TEG 5000 Thromboelastograph Coagulation Analyzer

Name: Z-1796-2013 TEG 5000 Thromboelastograph Coagulation Analyzer
Creator: Haemonetics Corporation
Published: 2013-06-20
License: https://open.fda.gov/license/

Haemonetics Corporation / initiated 2013-06-20 / Terminated / root cause: labeling and UDI

FDA source

Haemonetics Corporation began a recall of TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies on 2013-06-20. FDA classified it as Class II and gives the reason as "Research Use Only (RUO) parameters were included in TEG 5000 User Manual". 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-1796-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-20
Posted: 2013-07-24
Terminated: 2015-06-04
Recalling firm: Haemonetics Corporation
Product: TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
Reason for recall: Research Use Only (RUO) parameters were included in TEG 5000 User Manual.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Haemonetics sent a Medical Device Correction letter dated June 20, 2013 to all affected customers. The letter identified the affected product, problem and action to be taken. The letter instructs customers to discard the current manuals and replace with revised manuals included with the Customer Notification Letter. A Consignee Response Form has been included with the letter, which is to be signed and returned for effectiveness purposes. Follow up will be made to customers who don't return the Response Form. For questions contact TEG Technical Support team at 1-800-438-2834.
Quantity in commerce: 1590 devices
Distribution: US Nationwide
Product codes and lots: Per recall strategy.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1796-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1796-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-24

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)