Recall Z-0454-2009 ยท JQW Station, Pipetting And Diluting, For Clinical Use
Beckman Coulter Inc
Vidiera NsP Nucleic Sample Preparation, Part Number: A22421, Version 1.0.41
| Date | Dec 16, 2008 (initiated Aug 30, 2007) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 6 |
| Distribution | Nationwide distribution including states of PA, MI, UT, WA, IL, and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.