Z-1738-2011

TEG 5000 Thrombelastograph Hemostasis Analyzer System; a multipurpose system for in vitro coagulation...

Name: Z-1738-2011 TEG 5000 Thrombelastograph Hemostasis Analyzer System; a multipurpose system for in vitro coagulation...
Creator: Haemoscope Division of Haemonetics Corp
Published: 2011-01-28
License: https://open.fda.gov/license/

Haemoscope Division of Haemonetics Corp / initiated 2011-01-28 / Terminated

FDA source

Haemoscope Division of Haemonetics Corp began a recall of TEG 5000 Thrombelastograph Hemostasis Analyzer System; a multipurpose system for in vitro coagulation studies; Haemonetics, Haemoscope Division, Niles, IL... on 2011-01-28. The reason FDA records is "Haemonetics has received a report of smoke from the unit with a power supply failure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1738-2011
Status: Terminated
Initiated: 2011-01-28
Posted: 2011-03-21
Terminated: 2012-03-12
Recalling firm: Haemoscope Division of Haemonetics Corp
Product: TEG 5000 Thrombelastograph Hemostasis Analyzer System; a multipurpose system for in vitro coagulation studies; Haemonetics, Haemoscope Division, Niles, IL 60714; list number 07-022 a multipurpose system for in vitro coagulation studies
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
Reason for recall: Haemonetics has received a report of smoke from the unit with a power supply failure.
FDA root cause: Other
Action: Haemoscope sent letters to all of their U.S. accounts on January 24, 2011, via certified mail. The letters listed guidelines regarding proper use of the TEG 5000 System Power Supply to eliminate any potential risks such as electrical shorting or power supply damage. The information, which was printed in the letter, will also be available in an updated TEG User Manual soon to be released. A Caution label with installation instructions was included with the letter, to be applied to the back of the TEG unit. The accounts were requested to complete the enclosed acknowledgement form and fax it back to Haemoscope at 847-588-0455. Any questions were directed to 1-800-438-2834.
Quantity in commerce: 1,155 units
Distribution: Nationwide Distribution including CA, FL, MD, PA, OH, SC, TN, TX, and VA
Product codes and lots: list 07-022 (TEG 5000), all serial numbers

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)