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U.S. Department of Health and Human Services

Class 3 Device Recall ProSpecT Giardia/Cryptosporidium Microplate Assay.

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 Class 3 Device Recall ProSpecT Giardia/Cryptosporidium Microplate Assay.see related information
Date Initiated by FirmDecember 09, 2003
Date PostedAugust 17, 2004
Recall Status1 Terminated 3 on September 15, 2004
Recall NumberZ-1375-04
Recall Event ID 29680
510(K)NumberK955157 
Product Classification Giardia Spp. - Product Code MHI
ProductProSpecT Giardia/Cryptosporidium Microplate Assay. Catalog #: 2458496.
Code Information 944755
Recalling Firm/
Manufacturer		 Remel, Inc.
12076 Santa Fe Trail Dr
(PO Box 14478, zip 66285-4478)
Lenexa KS 66215-3519
Manufacturer Reason
for Recall		The conjugate may cause the negative control to produce high OD readings, therefore invalidating the run.
FDA Determined
Cause 2		Other
ActionRemel contacted each customer with a letter, by mail, requesting a count of the affected lots to be returned. Product would be replaced upon customer request.
Quantity in Commerce127 kits
DistributionUS and OUS customers.
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 = MHI
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