—#71828

Product

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

FDA product code: JQW — Station, Pipetting And Diluting, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Part Numbers: A22421, Version 1.0.41

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern: Nationwide distribution including states of PA, MI, UT, WA, IL, and CA.

Timeline

Recall initiated: 2007-08-30
Posted by FDA: 2008-12-16
Terminated: 2009-01-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #71828. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.