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U.S. Department of Health and Human Services

Enforcement Report - Week of May 1, 2013

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Event Detail

Event ID 64576
Product Type Biologics
Status Ongoing
Recalling Firm Micro Typing Systems, Inc.
City Pompano Beach
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-05
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Canada; Multiple U.S. States

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
MTS Anti-IgG Cards (Catalog # MTS 084024) 08071200134 , 09061200105, 09061200107, 09061200109, 09061200111, 09061200115, 09061200119, 09061200121, 09061200124, 09061200128, 09061200129, 10041200104, 10041200111, 10041200113, 10041200115, 10041200119 Class III In-vitro diagnostic test cards, associated with complaints of an incomplete foil seal for specific lots of ID-Micro Typing System Gel Cards, were distributed. 16 B-1236-13
MTS A/B/D Monoclonal and Reverse Grouping Card (Product Code MTS080515) 09131203710 Class II In-vitro diagnostic test cards, associated with complaints of an incomplete foil seal for specific lots of ID-Micro Typing System Gel Cards, were distributed. 1 B-1237-13
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