FDA Device

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

Hazard

Haemoscope received a report that during the process of Validation, Level II QC was running with an out-of-range low MA (Maximum Amplitude).

What You Should Do

Remedy

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 .

Products

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 f
Brand
Haemoscope Division of Haemonetics Corp
UPC
part number 07-008, catalog number REF 8002, lot numbers HMO196 and HMO197, expiration date July 2011

Units Affected

568 kits