Z-1229-2012

Synchron CX Immuno-Protein Cal, part number: 442840, other

Name: Z-1229-2012 Synchron CX Immuno-Protein Cal, part number: 442840, other
Creator: Beckman Coulter Inc.
Published: 2009-08-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2009-08-26 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Synchron CX Immuno-Protein Cal, part number: 442840, other product code: CKA The Beckman Coulter SYNCHRON CX Immune Protein Calibrator Set, in conjunction with... on 2009-08-26. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1229-2012
Status: Terminated
Initiated: 2009-08-26
Posted: 2012-03-20
Terminated: 2012-04-17
Recalling firm: Siemens Healthcare Diagnostics Inc.
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).
Product code: JIT Calibrator, Secondary
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 1,923 units total (1,882 units in US)
Distribution: Worldwide Distribution - USA (nationwide) and Canada
Product codes and lots: Lot Number: M901330 and higher Other Lot numbers: M706000, M801451, M808220

Product code JIT

K883181Class ISynchron Cx4/cx5 Clinical Chemistry Analyzer ReageBeckman Instruments, Inc. / cleared 1988-09-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)