TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit for Thrombelastograph Coagulation Analyz
FDA device recall Z-2742-2011 · posted 2011-07-06 · Terminated
Recall details
- Recalling firm
- Haemoscope Division of Haemonetics Corp
- 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).
- Action taken
- 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
- Status
- Terminated
- Product code
- JPA
- Quantity affected
- 568 kits
- Distribution
- Worldwide Distribution: (USA) Nationwide and the countries of Canada, Czech Republic and the Philippines
- Date initiated
- 2011-03-04
- Date posted
- 2011-07-06
- Date terminated
- 2012-09-25
- Location
- Niles, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES (K002177) | Haemoscope Corp. | 2000-09-14 |