Z-0316-04

VIDAS Lyme IgG and IgM LYT, Ref #30 298, containing 60 LYT STR (reagent strip labels), 2 x 30 LYT SPR (Solid...

Name: Z-0316-04 VIDAS Lyme IgG and IgM LYT, Ref #30 298, containing 60 LYT STR (reagent strip labels), 2 x 30 LYT SPR (Solid...
Creator: Biomerieux, Inc.
Published: 2003-10-28
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2003-10-28 / Terminated

FDA source

Biomerieux, Inc. began a recall of 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... on 2003-10-28. The reason FDA records is "Kit may contain incorrect components". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0316-04
Status: Terminated
Initiated: 2003-10-28
Posted: 2004-07-20
Terminated: 2004-08-13
Recalling firm: bioMerieux, Inc.
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.
Product code: LSR Reagent, Borrelia Serological Reagent
Reason for recall: Kit may contain incorrect components
FDA 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 in commerce: 329 kits
Distribution: Distribution was made nationwide to hospitals and laboratories.
Product codes and lots: Lot #777450001

Product code LSR

K943812Class IIVidas Lyme Screen IIBiomerieux Vitek, Inc. / cleared 1995-06-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)