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U.S. Department of Health and Human Services

Class 1 Device Recall

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 Class 1 Device Recallsee related information
Date Initiated by FirmMay 05, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on July 24, 2007
Recall NumberZ-1000-04
Recall Event ID 29060
Product Classification Station, Pipetting And Diluting, For Clinical Use - Product Code JQW
ProductTecan clinical workstation; 10-415 Tecan Genesis 150 front end, Roche catalog number 03585379001.
Code Information All units (serial numbers 5524, 6177, 6224, 6376, 6393, 6395, 6397, 6557, 7150, 7349, 7350, 7594, 7616 and 7724).
FEI Number 1823260
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
800-526-1247
Manufacturer Reason
for Recall		Tecan software has the potential to match the patient with a different patient's test results.
FDA Determined
Cause 2		Other
ActionPress release was issued 5/7/04 and recall letter dated 5/5/04 was sent to user laboratories.
Quantity in Commerce14
DistributionNationwide. California, Connecticut, Georgia, Illinois, Maryland, Massachusetts, Michigan, New Jersey, Pennsylvania, Tennessee, Texas and Wisconsin.
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.
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