Bayer HealthCare LLC, Diagnostics Div
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.]
| Date | Jun 21, 2003 (initiated Jun 19, 2003) |
| Status | Terminated |
| Reason | Analyzer will produce erroneous results due to missing grounding strap. |
| 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 | 1324 |
| Distribution | United States, Australia, Canada, Colombia, France, Germany, Hong Kong, India, Japan, Korea, Mexico, Sweden, Switzerland and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960546 | CLINITEK 50 URINE CHEMISTRY ANALYZER Bayer Corp., Jun 12, 1996 |