Recall Z-0851-2010
Beckman Coulter Inc · initiated May 29, 2008
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.
Codes / lots: All Software Versions.
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.
FDA-determined cause: Pending
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.
Details
- Recall number
- Z-0851-2010
- Initiated
- May 29, 2008
- Posted by FDA
- February 25, 2010
- Terminated
- November 29, 2011
- Product code
- KPA – Slide Stainer, Automated
- Quantity
- 4
- Distribution
- Worldwide Distribution -- USA and Canada.
- Recalling firm
- Beckman Coulter Inc, Brea, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0850-2010 | COULTER LH SlideMaker, LH Barcode Specification, LH SM Intended Use, LH Slide and Sample…Beckman Coulter has become aware of a potential issue in which the Sample ID information embedded in the… | 05/29/2008Terminated |