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U.S. Department of Health and Human Services

Class 2 Device Recall BIORAD ANTIBORRELIA (LYME) MICROPLATE EIA Kit

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 Class 2 Device Recall BIORAD ANTIBORRELIA (LYME) MICROPLATE EIA Kitsee related information
Date Initiated by FirmFebruary 11, 2013
Date PostedMarch 08, 2013
Recall Status1 Terminated 3 on August 27, 2013
Recall NumberZ-0927-2013
Recall Event ID 64348
510(K)NumberK911590 
Product Classification Reagent, borrelia serological reagent - Product Code LSR
ProductANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease.
Code Information Lot #120960 (121003. 121058,121002), ; Exp./Cad/Verw/bis: 2013-09; Catalog#802-3011; 25271, 25272, 25273; Label P/N 522-0040, 522-0037, 522-0011
FEI Number 2027113
Recalling Firm/
Manufacturer		 Innominata Dba Genbio
15222 Avenue Of Science Ste A
San Diego CA 92128-3422
For Additional Information ContactBryan Kiehl
858-592-9300
Manufacturer Reason
for Recall		Multiple incidents of low-reacting assay plates.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe firm, Innominata dba GenBio, sent an "Urgent Product Correction" letter dated February 11, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to review the listed questions to determine sites risk and take the appropriate actions. For questions regarding this issue, customers may contact Bio-Rad Technical Support at : 1-800-224-6723, option #2, and then option #3 for assistance.
Quantity in Commerce195
DistributionNationwide distribution: CA, IL, MA, MD, ME, NC, ND, NJ, NY, OR, VA and WI.
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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