FDA Recall
Terminated
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.]
Recall: Z-0911-03
·
Initiated June 19, 2003
Recall
- Recall Number
- Z-0911-03
- Event Number
- 26312
- Firm
- Bayer HealthCare LLC, Diagnostics Div
- FEI Number
- 1810909
- Status
- Terminated
- Root Cause
- Other
- Initiated
- June 19, 2003
- Posted
- June 21, 2003
- Terminated
- September 2, 2004
- Address
- 1884 Miles Ave., Elkhart, IN, 46515
Description
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
Analyzer will produce erroneous results due to missing grounding strap.
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.
Distribution
United States, Australia, Canada, Colombia, France, Germany, Hong Kong, India, Japan, Korea, Mexico, Sweden, Switzerland and United Kingdom.
Quantity
1324