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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Product Detail

Product Description Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits
Recall Number Z-1479-2013
Classification Class III
Code Info Product Code: CCG-9972; Lot: CCG-0281
Product Distributed Qty 504 units
Reason For Recall Affected products have a labeled expiration date of one year too long.

Event Detail

Event Id 64164
Product Type Devices
Status Completed
Recalling Firm Bion Enterprises Ltd
City Des Plaines
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-23
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Worldwide Distribution - United States (nationwide) in the states of IN, SC and the countries of Canada (Toronto); South Africa (Randburg) and Brazil (Rio de Janeiro)