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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 Firm December 09, 2003
Date Posted August 17, 2004
Recall Status1 Terminated 3 on September 15, 2004
Recall Number Z-1375-04
Recall Event ID 29680
510(K)Number K955157  
Product Classification Giardia Spp. - Product Code MHI
Product ProSpecT 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
Action Remel 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 Commerce 127 kits
Distribution US and OUS customers.
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 = MHI and Original Applicant = ALEXON BIOMEDICAL, INC.
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