Z-0454-2009

Vidiera NsP Nucleic Sample Preparation, Part Number: A22421, Version 1.0.41

Name: Z-0454-2009 Vidiera NsP Nucleic Sample Preparation, Part Number: A22421, Version 1.0.41
Creator: Beckman Coulter Inc
Published: 2007-08-30
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2007-08-30 / Terminated / root cause: software

FDA source

Beckman Coulter Inc began a recall of Vidiera NsP Nucleic Sample Preparation, Part Number: A22421, Version 1.0.41 on 2007-08-30. The reason FDA records is "Incorrect results: under certain circumstances, when transfer volume is not within the set range, the Vidiera NsP software does not report sample exclusion and does not flag the excluded sample in the "Run Results"...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0454-2009
Status: Terminated
Initiated: 2007-08-30
Posted: 2008-12-16
Terminated: 2009-01-13
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Vidiera NsP Nucleic Sample Preparation, Part Number: A22421, Version 1.0.41
Product code: JQW Station, Pipetting And Diluting, For Clinical Use
Reason for recall: Incorrect results: under certain circumstances, when transfer volume is not within the set range, the Vidiera NsP software does not report sample exclusion and does not flag the excluded sample in the "Run Results" report. The software error associated with the excluded sample appears as "Liquid was not successfully transferred to well#..........the sample will be excluded from further proce
Root cause tag: software
FDA root cause: Software design
Action: The customer notifications were initiated by Beckman Coulter on September 11, 2007 when all affected accounts were contacted via telephone, followed by a Product Corrective Action (PCA) was mailed via US Postal Service to all affected customers. The PCA informed the customers of the issue and instructed them to: (1) Review the "run Summary" event log for your samples. (2) Review the attached instructions describing the steps for identifying the samples affected by this error. (3) Complete and return the enclosed response form within 10 days so that we may maintain our records. The letter informed the customers that Beckman Coulter would provide a software update within 60 days. The letter also asked their customers to share the PCA with their staff and provide a copy of the PCA to any customers that they may have forwarded the affected products to. For questions regarding the PCA, please contact firm at 714-961-3634.
Quantity in commerce: 6
Distribution: Nationwide distribution including states of PA, MI, UT, WA, IL, and CA.
Product codes and lots: Part Numbers: A22421, Version 1.0.41

Product code JQW

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)