Beckman Coulter Inc.: Medical Device Recall in 2012 - (Recall #: Z-0123-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

UniCel¿ DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel¿ DxC Synchron¿ Clinical Systems are fully automated, computercontrolled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).

Product Classification:

Class II

Date Initiated: September 3, 2012

Date Posted: October 31, 2012

Recall Number: Z-0123-2013

Event ID: 63143

Reason for Recall:

Beckman Coulter has confirmed that the Shuttle to Barcode Reader and Cap Piercer alignment procedure cannot be performed on certain DxC configurations with v5.0.11 software installed. If the Shuttle to Barcode Reader becomes misaligned, the Operator will not be able to perform this alignment procedure on the DxC systems listed above. Software v5.0 .11 does not allow access to the Shuttle to Bar

Status: Terminated

Product Quantity: 7 units total (both US and International)

Code Information:

Part Number B12218. Serial numbers 2329, 5477, 5479.

Distribution Pattern:

Worldwide Distribution - USA including TX and OH. Interntionally to China and Turkey

Voluntary or Mandated:

Voluntary: Firm initiated