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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmSeptember 30, 2002
Date PostedJuly 19, 2003
Recall Status1 Terminated 3 on July 18, 2003
Recall NumberZ-1030-03
Recall Event ID 26478
510(K)NumberK002609 
ProductRoche/Hitachi Tina-quant RF II; catalog # 3004902
Code Information All lots
FEI Number 1823260
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Road
Indianapolis IN 46250-0457
For Additional Information Contactcustomer service
800-722-7222
Manufacturer Reason
for Recall		Test results may exhibit a positive bias when plasma samples are used for the assay.
FDA Determined
Cause 2		Other
ActionA reagent bulletin dated 9/30/02 was sent to all users. Customers were instructed to discontinue the use of plasma samples with this reagent.
Quantity in Commerce480
DistributionUnited States
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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