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U.S. Department of Health and Human Services

Class 3 Device Recall Clinitek

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 Class 3 Device Recall Cliniteksee related information
Date Initiated by FirmMarch 12, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on September 14, 2004
Recall NumberZ-1051-04
Recall Event ID 29444
510(K)NumberK960546 
Product Classification Automated Urinalysis System - Product Code KQO
ProductClinitek 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).
Code Information Serial numbers 166837 through 168088.
FEI Number 1810909
Recalling Firm/
Manufacturer		 Bayer Healthcare LLC
1884 Miles Ave
Buildings 110 (Adlake), 17 & 18
Elkhart IN 46514-2291
For Additional Information Contact
877-229-3711
Manufacturer Reason
for Recall		Some units may only have had 1 read head screw installed instead of the three required by the firm's specifications.
FDA Determined
Cause 2		Other
ActionConsignees were notified by recall letter on or about March 12, 2003 requesting customers to return their units for inspection and rework.
Quantity in Commerce424
DistributionUnited States, Australia, Canada, France, Germany, India, Japan, Netherlands, Poland, South Korea, Sweden, Switzerland and United Kingdom.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KQO
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