Class II — Beckman Coulter Inc.
| Recalling firm | BECKMAN COULTER, INC. |
|---|---|
| Registered facility | View this company's 22 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 |
| Product | 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). |
| Quantity | 7 units total (both US and International) |
| Distribution | Worldwide Distribution - USA including TX and OH. Interntionally to China and Turkey |
| Initiated | 2012-09-03 |
| Classified | 2012-10-24 |
| Terminated | 2014-02-14 |
| Recall number | Z-0123-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Beckman Coulter Inc. (Z-0123-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63143/
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