SYNCHRON Systems Salicylate (SALY) Reagent; Part Number: 378194. SALY reagent, when used in conjunction with SUNCHRON LX
FDA device recall Z-2238-2009 · posted 2009-09-30 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- The Salicylate Reagent lots listed here may fail calibration and/or fail to maintain linearity at the upper end of analytical range.
- Action taken
- An "Urgent: Product Corrective Action" letter dated October 22, 2007 was issued to customers. Customers were instructed to do the following: 1) Discontinue use and discard appropriately the affected lots of Salicylate Reagent., 2) Contact your Customer Service Representatives at 1-800-526-3821 in the United States or local Beckman Coulter Representative to discuss replacement options and 3) Complete and return the enclosed response form within 10 days. Contact your Customer Service Representative at 1-800-526-3821 in the United States or 1-800-463-7828 in Canada or, if you are outside the United States or Canada, please contact your local Beckman Coulter Representative to discuss replacement options. Direct any questions regarding this Product Corrective Action letter to the Customer Support Center (Hotline) at 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, please contact your local Beckman Coulter Representative.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DKJ
- Quantity affected
- 7,842 total
- Distribution
- Nationwide and Canada.
- Date initiated
- 2007-10-22
- Date posted
- 2009-09-30
- Date terminated
- 2012-07-16
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR (K014173) | Beckman Coulter, Inc. | 2002-02-15 |