Z-0851-2010

GENS SlideMaker, Barcode Label Specifications, GENS SM Intended Use, GEN*S Slide and Sample, Part Numbers...

Name: Z-0851-2010 GEN*S SlideMaker, Barcode Label Specifications, GEN*S SM Intended Use, GEN*S Slide and Sample, Part Numbers...
Creator: Beckman Coulter Inc
Published: 2008-05-29
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2008-05-29 / Terminated / root cause: labeling and UDI

FDA source

Beckman Coulter Inc began a recall of 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... on 2008-05-29. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0851-2010
Status: Terminated
Initiated: 2008-05-29
Posted: 2010-02-25
Terminated: 2011-11-29
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: KPA Slide Stainer, Automated
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.
Root cause tag: labeling and UDI
FDA root cause: Pending
Action: 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.
Quantity in commerce: 4
Distribution: Worldwide Distribution -- USA and Canada.
Product codes and lots: All Software Versions.

Product code KPA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)