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U.S. Department of Health and Human Services

Class 2 Device Recall Clinitek

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 Class 2 Device Recall Cliniteksee related information
Date Initiated by FirmJune 19, 2003
Date PostedJune 21, 2003
Recall Status1 Terminated 3 on September 02, 2004
Recall NumberZ-0911-03
Recall Event ID 26312
510(K)NumberK960546 
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 168252 through 169574.
FEI Number 1810909
Recalling Firm/
Manufacturer		 Bayer HealthCare LLC, Diagnostics Div
1884 Miles Ave.
Elkhart IN 46515
For Additional Information Contact
877-229-3711
Manufacturer Reason
for Recall		Analyzer will produce erroneous results due to missing grounding strap.
FDA Determined
Cause 2		Other
ActionMarketing 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 in Commerce1324
DistributionUnited States, Australia, Canada, Colombia, France, Germany, Hong Kong, India, Japan, Korea, Mexico, Sweden, Switzerland and United Kingdom.
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 =
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