FDA Medical Device Recalls (openFDA)
Diagnostica Stago, Inc.: STA-R blood coagulation analyzer. Catalog Number 57160.
- Recall number
- Z-1422-05
- Recalling firm
- Diagnostica Stago, Inc.
- Product
- STA-R blood coagulation analyzer. Catalog Number 57160.
- Status
- Terminated
- Initiated
- 2005-06-20
- Posted
- 2005-08-30
- Terminated
- 2005-08-30
- Reason
- Concerning the STA-R blood coagulation analyzer, there is a possible failure mode associated with patient samples receiving prolonged exposure time to reagents during the cuvette roll change process.
- Root cause
- Other
- Action
- Alert on the problem was sent out on 6/20/2005 to all customers alerting the problem and instructions on how to prevent the problem. The units are not be to returned.
- Quantity
- 215 units
- Distribution
- Units were distributed to clinics and hospitals nationwide.
- Lot, serial or model codes
- All units distributed under Catalog Number 57160.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JPA
- Firm FEI
- 2245451
- Firm city
- Parsippany
- Firm state
- NJ
- 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