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.] Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.]
Brand
Bayer HealthCare LLC, Diagnostics Div
Lot Codes / Batch Numbers
serial numbers 168252 through 169574.
Products Sold
serial numbers 168252 through 169574.
Bayer HealthCare LLC, Diagnostics Div is recalling Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and 6518C. [T due to Analyzer will produce erroneous results due to missing grounding strap.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Analyzer will produce erroneous results due to missing grounding strap.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026