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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Product Detail

Product Description 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.
Recall Number Z-0927-2013
Classification Class II
Code Info 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
Product Distributed Qty 195
Reason For Recall Multiple incidents of low-reacting assay plates.

Event Detail

Event Id 64348
Product Type Devices
Status Completed
Recalling Firm Innominata Dba Genbio
City San Diego
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-11
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide distribution: CA, IL, MA, MD, ME, NC, ND, NJ, NY, OR, VA and WI.