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).
Recall
- Recall Number
- Z-1229-2012
- Event Number
- 61122
- Firm
- Beckman Coulter Inc.
- FEI Number
- 2050012
- Product Code
- JIT
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- August 26, 2009
- Posted
- March 20, 2012
- Terminated
- April 17, 2012
- Address
- 250 S Kraemer Blvd, Brea, CA, 92821-6232
Description
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).
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.
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.
Worldwide Distribution - USA (nationwide) and Canada
1,923 units total (1,882 units in US)