Recall Z-0316-04 ยท LSR Reagent, Borrelia Serological Reagent
Biomerieux, Inc.
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 fir
| Date | Jul 20, 2004 (initiated Oct 28, 2003) |
| Status | Terminated |
| Reason | Kit may contain incorrect components |
| Root cause | Other |
| 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. |
| Quantity | 329 kits |
| Distribution | Distribution was made nationwide to hospitals and laboratories. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943812 | VIDAS LYME SCREEN II Biomerieux Vitek, Inc., Jun 13, 1995 |