FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: Synchron Liquid Comprehensive Chemistry Control Serum. Part numbers: 660710, 657365.
- Recall number
- Z-1151-04
- Recalling firm
- Beckman Coulter Inc
- Product
- Synchron Liquid Comprehensive Chemistry Control Serum. Part numbers: 660710, 657365.
- Status
- Terminated
- Initiated
- 2003-04-01
- Posted
- 2004-07-23
- Terminated
- 2004-08-30
- Reason
- The quality control samples for Vancomycin would not recover correctly when compared to the S.I. unit values listed in the incorrectly printed product insert. The incorrectly printed values were higher than they should be by a factor of 3 (three).
- Root cause
- Other
- Action
- not on file
- Quantity
- 9730
- Distribution
- not on file
- Lot, serial or model codes
- Lots: M202040, M206290
- 510(k) numbers
- ["K013235"]
- PMA numbers
- not on file
- Product code
- LEH
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- 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