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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 Recall
BIORAD ANTIBORRELIA (LYME) MICROPLATE EIA Kit
see related information
Date Posted March 08, 2013
Recall Status1 Terminated on August 27, 2013
Recall Number Z-0927-2013
Recall Event ID 64348
Premarket Notification
510(K) Number
K911590 
Product Classification Reagent, Borrelia Serological Reagent - Product Code LSR
Product ANTI-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
Recalling Firm/
Manufacturer
Innominata Dba Genbio
15222 Avenue Of Science Ste A
San Diego, California 92128-3422
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Bryan Kiehl
858-592-9300
Manufacturer Reason
for Recall
Multiple incidents of low-reacting assay plates.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action The 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 Commerce 195
Distribution Nationwide distribution: CA, IL, MA, MD, ME, NC, ND, NJ, NY, OR, VA and WI.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LSR and Original Applicant = GENERAL BIOMETRICS, INC.
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