—#72732

Product

Xpect 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.

FDA product code: MHI — Giardia Spp.
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K031834
Affected lot / code info: 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

Why it was recalled

Faint grey test lines for Cryptosporidium may be visible which may be interpreted as false positive

Root cause (FDA determination)

Process control

Action the firm took

The 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.

Recalling firm

Firm: Remel, Inc
Address: 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

Distribution pattern: Worldwide Distribution --- including USA and countries of Canada and U.K.

Timeline

Recall initiated: 2008-08-11
Posted by FDA: 2008-09-19
Terminated: 2010-01-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72732. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.