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U.S. Department of Health and Human Services

Class 3 Device Recall ProSpecT Cryptosporidium Microplate Assay

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  Class 3 Device Recall ProSpecT Cryptosporidium Microplate Assay see related information
Date Initiated by Firm May 09, 2002
Date Posted August 17, 2004
Recall Status1 Terminated 3 on September 15, 2004
Recall Number Z-1376-04
Recall Event ID 29681
510(K)Number K031965  
Product Classification Cryptosporidium Spp. - Product Code MHJ
Product ProSpecT Cryptosporidium Microplate Assay. Catalog #2454096.
Code Information 910717 912101
Recalling Firm/
Manufacturer		 Remel, Inc.
12076 Santa Fe Trail Dr
(PO Box 14478, zip 66285-4478)
Lenexa KS 66215-3519
Manufacturer Reason
for Recall		 A potential stability problem has been identified with the Positive Controls in the referenced kit lots of the ProSpecT Cryptosporidium Microplate Assay. The Positive Control may NOT perform as intended through its expiration date and may invalidate an otherwise acceptable run. Quality control testing indicates the other reagents in these kits are performing as intended.
FDA Determined
Cause 2		 Other
Action A potential stability problem has been identified with the positive control in the ProSpecT CryptoSporidium Microplate Assay. The positive control may not perform as intended through its expiration date and may invalidate an otherwise acceptable run.
Quantity in Commerce 388 kits (187 - 910717, 201 - 912101)
Distribution in the US
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MHJ and Original Applicant = REMEL INC
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