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
FDA Recall Z-2742-2011 · Posted 2011-07-06
Recalling FirmHaemoscope Division of Haemonetics Corp
Recall StatusTerminated
Product CodeJPA
Date Initiated2011-03-04
Date Terminated2012-09-25
Product Quantity568 kits
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).
Firm 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 .
Root Cause
Other
Distribution Pattern
Worldwide Distribution: (USA) Nationwide and the countries of Canada, Czech Republic and the Philippines
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.