Z-0911-03

Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and 6518C. [The...

Name: Z-0911-03 Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and 6518C. [The...
Creator: Bayer HealthCare LLC, Diagnostics Div
Published: 2003-06-19
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2003-06-19 / Terminated

FDA source

Bayer HealthCare LLC, Diagnostics Div began a recall of Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and 6518C. [The different product codes are for the various countries... on 2003-06-19. The reason FDA records is "Analyzer will produce erroneous results due to missing grounding strap". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0911-03
Status: Terminated
Initiated: 2003-06-19
Posted: 2003-06-21
Terminated: 2004-09-02
Recalling firm: Medrad, Inc.
Product: Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and 6518C. [The different product codes are for the various countries where the product is distributed.]
Reason for recall: Analyzer will produce erroneous results due to missing grounding strap.
FDA root cause: Other
Action: Marketing sent a 'dear customer' letter to each account on May 13, 2003 telling them that their instrument had been identified as not meeting a production specification. An urgent product correction letter was subsequently sent to each account on or about June 20, 2003. The analyzers affected will be replaced.
Quantity in commerce: 1324
Distribution: United States, Australia, Canada, Colombia, France, Germany, Hong Kong, India, Japan, Korea, Mexico, Sweden, Switzerland and United Kingdom.
Product codes and lots: serial numbers 168252 through 169574.

K960546Class IClinitek 50 Urine Chemistry AnalyzerBayer Corp. / cleared 1996-06-12

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)