Recall Z-2238-2009 ยท DKJ Colorimetry, Salicylate
Beckman Coulter Inc
SYNCHRON Systems Salicylate (SALY) Reagent; Part Number: 378194. SALY reagent, when used in conjunction with SUNCHRON LX System(s), UniCel DxC 600/800 Systems(s), SYNCHRON CX Systems(s) and SYNCHRON Systems Salicylate Calibrator, is intended for the quantitative determination of Salicylate concentration in human serum of plasma.
| Date | Sep 30, 2009 (initiated Oct 22, 2007) |
| Status | Terminated |
| Reason | The Salicylate Reagent lots listed here may fail calibration and/or fail to maintain linearity at the upper end of analytical range. |
| Root cause | Nonconforming Material/Component |
| Action | 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 |
| Quantity | 7,842 total |
| Distribution | Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K014173 | SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR Beckman Coulter, Inc., Feb 15, 2002 |