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). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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).
Brand
Beckman Coulter Inc.
Lot Codes / Batch Numbers
Lot Number: M901330 and higher Other Lot numbers: M706000, M801451, M808220
Products Sold
Lot Number: M901330 and higher Other Lot numbers: M706000, M801451, M808220
Beckman Coulter Inc. is recalling Synchron CX Immuno-Protein Cal, part number: 442840, other product code: CKA The Beckman Coulter due to A recall was initiated because Beckman has confirmed that the standardization of the Immuno Protein Calibrator Set has been re-established to IFCC Ref. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026