CYTOSTAT tetraCHROME CD45FITC/CD56RD1/CD19ECD/CD3PC5 의 리콜

Recall

57445

Class 2

Z-1877-2011

2010-09-16

2011-04-04

Terminated

United States

2012-06-14

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96251

A labeling error resulted in the specimen age stability and the prepared sample stability being stated incorrectly in the instructions for use. there is no impact to the product safety or functionality.

An Urgent: Product Corrective Action letter dated, September 27, 2010, was sent to customers. The letter identified the affected product and stated the reasons for the recall. Customers were also asked to take the following actions: ACTION/RESOLUTION For issue 1: The specimen stability claims should be as follows: - 48 hours for both % positives and absolute counts for the CD45/4/8/3 tube - 24 hours for both % positives and absolute counts for the CD45/56/19/3 tube For Issue 2: Results produced are not impacted when samples are prepared and run within the post collection time frames provided in the product instructions for use: - Preparation within 72 hours of collection for the CD45/4/8/3 tube - Preparation within 24 hours of collection for CD45/56/19/3 tube Beckman Coulter requested consignees complete and return the enclosed response form within 10 days so they may maintain their records. The firm also asked that they share the information with laboratory staff, and retain this notification as part of their Quality System documentation. Questions regarding the Product Corrective Action were directed to (800) 526-7694 in the United States or (800) 463-7828 in Canada. If outside the US or Canada, consignees were instructed to contact their local Beckman Coulter Representative.