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U.S. Department of Health and Human Services

Class 3 Device Recall ProSpecT Giardia/Cryptosporidium Micorplate Assay.

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 Class 3 Device Recall ProSpecT Giardia/Cryptosporidium Micorplate Assay.see related information
Date Initiated by FirmNovember 21, 2002
Date PostedAugust 17, 2004
Recall Status1 Terminated 3 on September 15, 2004
Recall NumberZ-1374-04
Recall Event ID 29679
510(K)NumberK955157 
Product Classification Giardia Spp. - Product Code MHI
ProductProSpecT Giardia/Cryptosporidium Micorplate Assay. Catalog #: 2458496.
Code Information 926230
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 of the ProSpecT Giardia/Cryptosporidium Microplate Assay, Lot #926230, may have become contaminated during filling. The particulates in the contamination may cause the dropper tips to become plugged. Quality control testing indicated that the reagents were still performing as intended, including the conjugates.
FDA Determined
Cause 2		Other
ActionA potential contamination was noted in the conjugate in the ProSpecT Giardia/Cryptosporidium Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged.
Quantity in Commerce12
DistributionUS only
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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