—#30124

Product

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 product code: LSR — Reagent, Borrelia Serological Reagent
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K943812
Affected lot / code info: Lot #777450001

Why it was recalled

Kit may contain incorrect components

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Biomerieux, Inc.
Address: 100 Rodolphe St, Durham, North Carolina 27712-9402

Distribution

Distribution pattern: Distribution was made nationwide to hospitals and laboratories.

Timeline

Recall initiated: 2003-10-28
Posted by FDA: 2004-07-20
Terminated: 2004-08-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #30124. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.