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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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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)

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits Product Code: CCG-9912; Lot: CCG-0280 Class III Affected products have a labeled expiration date of one year too long. 207 units Z-1477-2013
Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits Product Code: CCM-9914; Lot: CCM-0281 Class III Affected products have a labeled expiration date of one year too long. 201 units Z-1478-2013
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 Product Code: CCG-9972; Lot: CCG-0281 Class III Affected products have a labeled expiration date of one year too long. 504 units Z-1479-2013
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