FDA Medical Device Recalls (openFDA)
Haemonetics Corporation: TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
- Recall number
- Z-1796-2013
- Recalling firm
- Haemonetics Corporation
- Product
- TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
- Status
- Terminated
- Initiated
- 2013-06-20
- Posted
- 2013-07-24
- Terminated
- 2015-06-04
- Reason
- Research Use Only (RUO) parameters were included in TEG 5000 User Manual.
- Root cause
- Labeling False and Misleading
- Action
- Haemonetics sent a Medical Device Correction letter dated June 20, 2013 to all affected customers. The letter identified the affected product, problem and action to be taken. The letter instructs customers to discard the current manuals and replace with revised manuals included with the Customer Notification Letter. A Consignee Response Form has been included with the letter, which is to be signed and returned for effectiveness purposes. Follow up will be made to customers who don't return the Response Form. For questions contact TEG Technical Support team at 1-800-438-2834.
- Quantity
- 1590 devices
- Distribution
- US Nationwide
- Lot, serial or model codes
- Per recall strategy.
- 510(k) numbers
- ["K002177"]
- PMA numbers
- not on file
- Product code
- JPA
- Firm FEI
- 1219343
- Firm city
- Braintree
- Firm state
- MA
- 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