FDA Medical Device Recalls (openFDA)
Haemoscope Division of Haemonetics Corp: 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
- Recall number
- Z-2742-2011
- 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
- Status
- Terminated
- Initiated
- 2011-03-04
- Posted
- 2011-07-06
- Terminated
- 2012-09-25
- Reason
- Haemoscope received a report that during the process of Validation, Level II QC was running with an out-of-range low MA (Maximum Amplitude).
- 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
- 568 kits
- Distribution
- Worldwide Distribution: (USA) Nationwide and the countries of Canada, Czech Republic and the Philippines
- Lot, serial or model codes
- part number 07-008, catalog number REF 8002, lot numbers HMO196 and HMO197, expiration date July 2011
- 510(k) numbers
- ["K002177"]
- PMA numbers
- not on file
- Product code
- JPA
- Firm FEI
- 2429444
- Firm city
- Niles
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28