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-1051-04 · Posted 2004-07-20
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Recalling FirmBayer Healthcare LLC
Recall StatusTerminated
Product CodeKQO
Date Initiated2004-03-12
Date Terminated2004-09-14
Product Quantity424
Reason for Recall
Some units may only have had 1 read head screw installed instead of the three required by the firm's specifications.
Firm Action
Consignees were notified by recall letter on or about March 12, 2003 requesting customers to return their units for inspection and rework.
Root Cause
Other
Distribution Pattern
United States, Australia, Canada, France, Germany, India, Japan, Netherlands, Poland, South Korea, 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.
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