Z-2432-2008

Xpect Giardia/Cryptosporidium Kit, Ref 24050520, 20 tests per kit, For In Vitro Diagnostic Use. A rapid test...

Name: Z-2432-2008 Xpect Giardia/Cryptosporidium Kit, Ref 24050520, 20 tests per kit, For In Vitro Diagnostic Use. A rapid test...
Creator: Remel, Inc
Published: 2008-08-11
License: https://open.fda.gov/license/

Remel Inc / initiated 2008-08-11 / Terminated / root cause: manufacturing process

FDA source

Remel, Inc began a recall of 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... on 2008-08-11. The reason FDA records is "Faint grey test lines for Cryptosporidium may be visible which may be interpreted as false positive". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2432-2008
Status: Terminated
Initiated: 2008-08-11
Posted: 2008-09-19
Terminated: 2010-01-21
Recalling firm: Remel Inc
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.
Product code: MHI Giardia Spp.
Reason for recall: Faint grey test lines for Cryptosporidium may be visible which may be interpreted as false positive
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 3,974 kits
Distribution: Worldwide Distribution --- including USA and countries of Canada and U.K.
Product codes and lots: 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

Product code MHI

K031834Class IIXpect Giardia/cryptosporidium Lateral Flow AssayRemel, Inc. / cleared 2003-11-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)