FDA Medical Device Recalls (openFDA)
Haemoscope Division of Haemonetics Corp: TEG 5000 Thrombelastograph Hemostasis Analyzer System; a multipurpose system for in vitro coagulation studies; Haemonetics, Haemoscope Division, Niles, IL 60714; list number 07-022 a multipurpose system for in vitro coagulation studies
- Recall number
- Z-1738-2011
- Recalling firm
- Haemoscope Division of Haemonetics Corp
- Product
- TEG 5000 Thrombelastograph Hemostasis Analyzer System; a multipurpose system for in vitro coagulation studies; Haemonetics, Haemoscope Division, Niles, IL 60714; list number 07-022 a multipurpose system for in vitro coagulation studies
- Status
- Terminated
- Initiated
- 2011-01-28
- Posted
- 2011-03-21
- Terminated
- 2012-03-12
- Reason
- Haemonetics has received a report of smoke from the unit with a power supply failure.
- Root cause
- Other
- Action
- Haemoscope sent letters to all of their U.S. accounts on January 24, 2011, via certified mail. The letters listed guidelines regarding proper use of the TEG 5000 System Power Supply to eliminate any potential risks such as electrical shorting or power supply damage. The information, which was printed in the letter, will also be available in an updated TEG User Manual soon to be released. A Caution label with installation instructions was included with the letter, to be applied to the back of the TEG unit. The accounts were requested to complete the enclosed acknowledgement form and fax it back to Haemoscope at 847-588-0455. Any questions were directed to 1-800-438-2834.
- Quantity
- 1,155 units
- Distribution
- Nationwide Distribution including CA, FL, MD, PA, OH, SC, TN, TX, and VA
- Lot, serial or model codes
- list 07-022 (TEG 5000), all serial numbers
- 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
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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