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.
This recall has been terminated (originally issued July 20, 2004).
- Company
- Biomerieux, Inc.
- Recall Initiated
- October 28, 2003
- Posted
- July 20, 2004
- Terminated
- August 13, 2004
- Recall Number
- Z-0316-04
- Quantity
- 329 kits
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
Reason for Recall
Kit may contain incorrect components
Distribution
Distribution was made nationwide to hospitals and laboratories.
Lot / Code Info
Lot #777450001
Root Cause
Other
Action Taken
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.
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