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U.S. Department of Health and Human Services

Class 2 Device Recall VIDAS Lyme IgG and IgM (LYT) Assay

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 Class 2 Device Recall VIDAS Lyme IgG and IgM (LYT) Assaysee related information
Date Initiated by FirmOctober 28, 2003
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on August 13, 2004
Recall NumberZ-0316-04
Recall Event ID 27577
510(K)NumberK943812 
Product Classification Reagent, Borrelia Serological Reagent - Product Code LSR
ProductVIDAS 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.
Code Information Lot #777450001
FEI Number 1039284
Recalling Firm/
Manufacturer		 Biomerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information ContactAnita M. McClernon, MS, RAC
919-620-2288
Manufacturer Reason
for Recall		Kit may contain incorrect components
FDA Determined
Cause 2		Other
ActionRecall 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 Commerce329 kits
DistributionDistribution was made nationwide to hospitals and laboratories.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LSR
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