Z-1440-06

UniCel DxC 600/600PRO/600i/800/800PRO Synchron Clinical Systems , Part Numbers: A20463-Software version 1.0...

Name: Z-1440-06 UniCel DxC 600/600PRO/600i/800/800PRO Synchron Clinical Systems , Part Numbers: A20463-Software version 1.0...
Creator: Beckman Coulter Inc
Published: 2006-05-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2006-05-15 / Terminated

FDA source

Beckman Coulter Inc began a recall of UniCel DxC 600/600PRO/600i/800/800PRO Synchron Clinical Systems , Part Numbers: A20463-Software version 1.0, A27331-Software version 1.2, A29764-Software... on 2006-05-15. The reason FDA records is "Incorrect Reagent Status-When a new cartridge of Infinity Lithium Reagent is loaded on to the UniCel DxC System, the Reagent Status screen will incorrectly show 'Days Left' as 21. The correct Reagent Status for a new...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1440-06
Status: Terminated
Initiated: 2006-05-15
Posted: 2006-08-26
Terminated: 2013-04-08
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: UniCel DxC 600/600PRO/600i/800/800PRO Synchron Clinical Systems , Part Numbers: A20463-Software version 1.0, A27331-Software version 1.2, A29764-Software version 1.4
Product code: NDW Assay, Porphyrin, Spectrophotometry, Lithium
Reason for recall: Incorrect Reagent Status-When a new cartridge of Infinity Lithium Reagent is loaded on to the UniCel DxC System, the Reagent Status screen will incorrectly show 'Days Left' as 21. The correct Reagent Status for a new Lithium reagent cartridge is 14 days. Lithium reagent used past 14 days may produce low quality control and/or patient results.
FDA root cause: Other
Action: A Product Correction Action (PCA) letter was sent the week of May 15, 2006 to all Unicel DxC customers informing them not to leave any Lithium reagent cartridge onboard a UniCel DxC System past 14 days. They also were instructed to complete and return the enclosed response form. The Letter was sent by US Mail.
Quantity in commerce: 524
Distribution: Nationwide and Canada
Product codes and lots: Part Numbers: A20463-Software version 1.0, A27331-Software version 1.2, A29764-Software version 1.4

Product code NDW

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)