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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 Kit see related information
Date Initiated by Firm February 11, 2013
Date Posted March 08, 2013
Recall Status1 Terminated 3 on August 27, 2013
Recall Number Z-0927-2013
Recall Event ID 64348
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 CA 92128-3422
For Additional Information Contact Bryan Kiehl
858-592-9300
Manufacturer Reason
for Recall		 Multiple incidents of low-reacting assay plates.
FDA Determined
Cause 2		 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 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) Database 510(K)s with Product Code = LSR and Original Applicant = GENERAL BIOMETRICS, INC.
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