Recall Z-1229-2012 ยท JIT Calibrator, Secondary
Beckman Coulter Inc.
Synchron CX Immuno-Protein Cal, part number: 442840, other product code: CKA The Beckman Coulter SYNCHRON CX Immune Protein Calibrator Set, in conjunction with SYNCHRON Immuno Protein Reagents, is intended for use on SYNCHRON CX Systems for the calibration of IgA, IgG, IgM, and Transferrin (TRF).
| Date | Mar 20, 2012 (initiated Aug 26, 2009) |
| Status | Terminated |
| Reason | A recall was initiated because Beckman has confirmed that the standardization of the Immuno Protein Calibrator Set has been re-established to IFCC Reference Preparation for Plasma Proteins, BCR-470 beginning with lot number M901330. |
| Root cause | Nonconforming Material/Component |
| Action | Beckman Coulter sent an Urgent Field Safety Notice letter dated August 24, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Customers with questions regarding the product correction action were instructed to contact their local Beckman Coulter Representative. For questions regarding this recall call 714-993-8916. |
| Quantity | 1,923 units total (1,882 units in US) |
| Distribution | Worldwide Distribution - USA (nationwide) and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K883181 | SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE Beckman Instruments, Inc., Sep 19, 1988 |