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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Update To Urgent Product Correction Notification MTS A/B/D Monoclonal and Reverse Grouping Card

 

DATE NOTIFICATION INITIATED: February 1, 2013
 
PRODUCT / LOT NUMBER / EXPIRATION DATE:
 
Product Name: MTS A/B/D Monoclonal and Reverse Grouping Card
Product Code: MTS080515
 

Affected Lot No.
Expiry Date
09131203710
3 July 2013

 
MANUFACTURER:
 
Micro Typing Systems
Pompano Beach, FL

 

REASON:
 
Ortho-Clinical Diagnostics, Inc. (OCD) issued a follow up to a previous Urgent Product Correction Notification dated November 5, 2012 regarding complaints of an incomplete foil seal for specific lots of ID-Micro Typing System Gel Cards. Due to additional information obtained since issuing the initial notification OCD is sending a follow-up communication regarding an additional lot of MTS A/B/D Monoclonal and Reverse Grouping Card. Consignees are asked to follow the instructions as outlined in the Update to Urgent Product Correction Notification. 
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The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.