—#72446

Product

GEN*S SlideMaker, Barcode Label Specifications, GEN*S SM Intended Use, GEN*S Slide and Sample, Part Numbers 6605360, P/N 4237221, 4237212, and 4277299. Intended for use as an optional peripheral to the COULTER GEN*S System. Creates a blood smear on a clean microscope slide using a segment of the blood sample aspirated by the GEN*S System.

FDA product code: KPA — Slide Stainer, Automated
Device class: Class 1
Medical specialty: Pathology
Affected lot / code info: All Software Versions.

Why it was recalled

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.

Root cause (FDA determination)

Pending

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- USA and Canada.

Timeline

Recall initiated: 2008-05-29
Posted by FDA: 2010-02-25
Terminated: 2011-11-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72446. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.