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U.S. Department of Health and Human Services

Class 2 Device Recall AMPLICOR HPV Microwell Plate Analyte Specific Reagent

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 Class 2 Device Recall AMPLICOR HPV Microwell Plate Analyte Specific Reagentsee related information
Date Initiated by FirmMarch 10, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on January 07, 2005
Recall NumberZ-0934-04
Recall Event ID 28739
ProductAMPLICOR HPV Microwell Plate Analyte Specific Reagent (MWP); catalog 03579229190.
Code Information Lot E12989; exp 7/04.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
800-428-5074
Manufacturer Reason
for Recall		Marketed without PMA or 510(k) approval.
FDA Determined
Cause 2		Other
ActionConsignees were notified of the removal by phone on 3/10/04.
Quantity in Commerce3
DistributionFlorida and Virginia.
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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