VIDAS Lyme IgG and IgM LYT, Ref #30 298, containing 60 LYT STR (reagent strip labels), 2 x 30 LYT SPR (Solid Phase Receptable) pouches, 1 x 1.5 ml LYT C1 (human) (positive control bottle), 1 x 1.5 ml LYT C2 (human) (negative control bottle), and 1 x 1.5 ml LYT S1 (human) (standard bottle). The responsible firm on the kit label is bioMerieux sa, 69280 Marcy l''Etoile France. The responsible firm on the insert is bioMerieux, Inc., Durham, NC.
FDA Recall Z-0316-04 · Posted 2004-07-20
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Recalling FirmBiomerieux, Inc.
Recall StatusTerminated
Product CodeLSR
Date Initiated2003-10-28
Date Terminated2004-08-13
Product Quantity329 kits
Reason for Recall
Kit may contain incorrect components
Firm Action
Recall letters dated 10/28/03 were issued via regular mail instructing the customer to examine the kits to determine whether they contain the CMV IgG SPRS and destroy them if found.
Root Cause
Other
Distribution Pattern
Distribution was made nationwide to hospitals and laboratories.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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