FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824.
- Recall number
- Z-0886-06
- Recalling firm
- Beckman Coulter Inc
- Product
- SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824.
- Status
- Terminated
- Initiated
- 2006-03-30
- Posted
- 2006-05-18
- Terminated
- 2012-02-29
- Reason
- Beckman Coulter has received reports of patient samples and quality control recovery shifting low when using Vancomycin reagent lots M507219 and M511327. Internal QC recovery was as much as 15% lower than the assigned target value.
- Root cause
- Other
- Action
- A Product Corrective Action (PCA) letter was be sent the week of MAR 30, 2006 to all SYNCHRON Systems Vancomycin Reagent customers of lot numbers M507219 and M511327 informing them to discontinue use and discard reagent. (Letters were sent by US mail)
- Quantity
- 3147
- Distribution
- Nationwide & Canada
- Lot, serial or model codes
- Lot numbers M507219 & M511327
- 510(k) numbers
- ["K013076"]
- 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