Bayer Healthcare LLC 1884 Miles Ave Buildings 110 (Adlake), 17 & 18 Elkhart IN 46514-2291 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 1884 Miles Ave Buildings 110 (Adlake), 17 & 18 Elkhart IN 46514-2291
Lot Codes / Batch Numbers
Serial numbers 166837 through 168088.
Products Sold
Serial numbers 166837 through 168088.
Bayer Healthcare LLC 1884 Miles Ave Buildings 110 (Adlake), 17 & 18 Elkhart IN 46514-2291 is recalling Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and 6518C. [Th due to Some units may only have had 1 read head screw installed instead of the three required by the firm's specifications.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Some units may only have had 1 read head screw installed instead of the three required by the firm's specifications.
Recommended Action
Per FDA guidance
Consignees were notified by recall letter on or about March 12, 2003 requesting customers to return their units for inspection and rework.
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