GEN*S SlideMaker, Barcode Label Specifications, GEN*S SM Intended Use, GEN*S Slide and Sample, Part Numbers 6605360, P/N

FDA device recall Z-0851-2010 · posted 2010-02-25 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc

Reason for recall

Beckman Coulter has become aware of a potential issue in which the Sample ID information embedded in the barcode affixed to a slide made by the Coulter GEN*S and LH SlideMaker does not match the text.

Action taken

An Urgent: Product Corrective Action letter, dated June 9, 2008, was sent to customers. The letter identified the affected products, stated the background, discussed the issue, and stated the actions to be taken. Customers are to: 1. Only use upper case alpha characters in the Sample Identifier 2. If you must use lower case alpha characters in the Sample Identifier, configure the SlideMaker Slide labels without a bar-code. Questions regarding the Product Corrective Action should be directed to Beckman Coulter Customer Service at 1-800-526-7694 or your local Beckman Coulter Rep.

Root cause

Pending

Status

Terminated

Product code

KPA

Quantity affected

4

Distribution

Worldwide Distribution -- USA and Canada.

Date initiated

2008-05-29

Date posted

2010-02-25

Date terminated

2011-11-29

Location

Brea, CA