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.]
FDA Recall Z-0911-03 · Posted 2003-06-21
Advertisement
Recalling FirmBayer HealthCare LLC, Diagnostics Div
Recall StatusTerminated
Date Initiated2003-06-19
Date Terminated2004-09-02
Product Quantity1324
Reason for Recall
Analyzer will produce erroneous results due to missing grounding strap.
Firm 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.
Root Cause
Other
Distribution Pattern
United States, Australia, Canada, Colombia, France, Germany, Hong Kong, India, Japan, Korea, Mexico, Sweden, Switzerland and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement