Z-2742-2011

TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit for Thrombelastograph...

Name: Z-2742-2011 TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit for Thrombelastograph...
Creator: Haemoscope Division of Haemonetics Corp
Published: 2011-03-04
License: https://open.fda.gov/license/

Haemoscope Division of Haemonetics Corp / initiated 2011-03-04 / Terminated

FDA source

Haemoscope Division of Haemonetics Corp began a recall of TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit for Thrombelastograph Coagulation Analyzer TEG 5000 Series Used as the... on 2011-03-04. The reason FDA records is "Haemoscope received a report that during the process of Validation, Level II QC was running with an out-of-range low MA (Maximum Amplitude)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2742-2011
Status: Terminated
Initiated: 2011-03-04
Posted: 2011-07-06
Terminated: 2012-09-25
Recalling firm: Haemoscope Division of Haemonetics Corp
Product: TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit for Thrombelastograph Coagulation Analyzer TEG 5000 Series Used as the operational check and calibration verification for the TEG 5000 Thrombelastograph Hemostasis Analyzer System
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
Reason for recall: Haemoscope received a report that during the process of Validation, Level II QC was running with an out-of-range low MA (Maximum Amplitude).
FDA root cause: Other
Action: Haemoscope, a Division of Haemonetics Corp, sent a letter dated March 2, 2011 to all of the affected customers. The letters informed the customers that Haemoscope had received a higher than normal inquiry rate for the Level II Quality Control Kits, part 07-008, lots HMO196 and HMO 197. The accounts were requested to return their stocks of those two lots for further testing and evaluation and to complete the enclosed acknowledgement form, confirming receipt of the letter and the number of kit boxes being returned, and fax it back to Haemoscope at 847-588-0455. The returned kits will be replaced at no charge. For additional information please contact Haemoscope at 847-588-0453, ext-217 .
Quantity in commerce: 568 kits
Distribution: Worldwide Distribution: (USA) Nationwide and the countries of Canada, Czech Republic and the Philippines
Product codes and lots: part number 07-008, catalog number REF 8002, lot numbers HMO196 and HMO197, expiration date July 2011

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)