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

FDA device recall Z-2432-2008 · posted 2008-09-19 · Terminated

Recall details

Recalling firm

Remel, Inc

Reason for recall

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

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

MHI

Quantity affected

3,974 kits

Distribution

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

Date initiated

2008-08-11

Date posted

2008-09-19

Date terminated

2010-01-21

Location

Lenexa, KS

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