Recall Z-2432-2008 ยท MHI Giardia Spp.
Remel, Inc
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.
| Date | Sep 19, 2008 (initiated Aug 11, 2008) |
| Status | Terminated |
| Reason | Faint grey test lines for Cryptosporidium may be visible which may be interpreted as false positive |
| 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 Produc |
| Quantity | 3,974 kits |
| Distribution | Worldwide Distribution --- including USA and countries of Canada and U.K. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031834 | XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY Remel, Inc., Nov 10, 2003 |