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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
BIO-RAD ANTI-BORRELIA (LYME) MICROPLATE EIA Kit		see related information
Date Posted March 08, 2013
Recall Number Z-0927-2013
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
For Additional Information Contact Bryan Kiehl
858-592-9300
Reason for
Recall		 Multiple incidents of low-reacting assay plates.
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.
 
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