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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 Incomplete Foil Seal on Specific Lots of MTS Anti-IgG Cards

 

DATE NOTIFICATION INITIATED: February 7, 2013
 
PRODUCT / LOT NUMBER / EXPIRATION DATE:
 
Product Name: MTS Anti-IgG Card
Product Code: MTS084024
 

Affected Lot No.
Expiry Date
08071200134
17 June 2013
09061200105
19 June 2013
09061200107
20 June 2013
09061200109
20 June 2013
09061200111
24 June 2013
09061200115
25 June 2013
09061200119
26 June 2013
09061200121
26 June 2013
09061200124
8 July 2013
09061200128
10 July 2013
09061200129
11 July 2013
10041200104
18 July 2013
10041200111
22 July 2013
10041200113
23 July 2013
10041200115
23 July 2013
10041200119
24 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 additional lots of MTS Anti-IgG Cards. 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.