Synchron CX Immuno-Protein Cal, part number: 442840, other product code: CKA The Beckman Coulter SYNCHRON CX Immune Prot
FDA device recall Z-1229-2012 · posted 2012-03-20 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JIT
- Quantity affected
- 1,923 units total (1,882 units in US)
- Distribution
- Worldwide Distribution - USA (nationwide) and Canada
- Date initiated
- 2009-08-26
- Date posted
- 2012-03-20
- Date terminated
- 2012-04-17
- 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 CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE (K883181) | Beckman Instruments, Inc. | 1988-09-19 |