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U.S. Department of Health and Human Services

Class 2 Device Recall Xpect Giardia/Cryptosporidium Kit

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 Class 2 Device Recall Xpect Giardia/Cryptosporidium Kitsee related information
Date Initiated by FirmAugust 11, 2008
Date PostedSeptember 19, 2008
Recall Status1 Terminated 3 on January 21, 2010
Recall NumberZ-2432-2008
Recall Event ID 49090
510(K)NumberK031834 
Product Classification Giardia Spp. - Product Code MHI
ProductXpect Giardia/Cryptosporidium Kit, Ref 24050520, 20 tests per kit, For In Vitro Diagnostic Use. A rapid test for the direct qualitative detection of Giardia and Cryptosporidium antigens in fecal specimens.
Code Information Lot numbers 597374, Exp. 2008.10.08; 607636, Exp. 2008.11.06; 615970, Exp. 2008.12.02; 615971, Exp. 2008.12.02; 621187, Exp. 2008.12.02; 622617, Exp. 2009.04.02; 624618, Exp. 2009.01.02; 635553, Exp. 2009.04.17; 635554, Exp. 2009.04.24; 640609, Exp. 2009.05.01; 654829, Exp. 2009.05.30; and 658878, Exp. 2009.05.30
Recalling Firm/
Manufacturer		 Remel, Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information ContactRobert Booth
913-895-4007
Manufacturer Reason
for Recall		Faint grey test lines for Cryptosporidium may be visible which may be interpreted as false positive
FDA Determined
Cause 2		Process control
ActionThe recalling firm issued letters dated 6/19/08 flagged "IMPORTANT PRODUCT INFORMATION" which advised their customers of the issue with the faint grey test lines but did not request any action be taken, such as return or destruction of the affected lot numbers. The recalling firm issued a second letter flagged "IMPORTANT MEDICAL DEVICE CUSTOMER ADVISORY NOTICE" dated 8/11/08 and was issued via regular mail on 8/14/08. This letter asked users to review their inventory for the product lots indicated in the letter, discard all remaining units of this product lot, complete and return the Product Inventory Checklist regardless if they have affected product. A "PRODUCT INVENTORY CHECKLIST" was enclosed to report whether the firm had product to discard and the amount to be replaced.
Quantity in Commerce3,974 kits
DistributionWorldwide Distribution --- including USA and countries of Canada and U.K.
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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