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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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URGENT PRODUCT CORRECTION NOTIFICATION-MTS™ Anti-IgG Cards

 


DATE NOTIFICATION INITIATED: November 5, 2012
  
PRODUCT / LOT NUMBER / EXPIRATION DATE:

Product Code
Product Name
Affected Lot No.
Expiry Date
 
 
 
 
 
 
 
 
 
MTS084024
 
 
 
 
 
 
 
 
 
MTS™ Anti-IgG Card
080712001-24
07 Jun 2013
080712001-25
07 Jun 2013
080712001-26
10 Jun 2013
080712001-27
10 Jun 2013
080712001-28
11 Jun 2013
080712001-29
11 Jun 2013
080712001-30
13 Jun 2013
080712001-31
14 Jun 2013
080712001-32
14 Jun 2013
080712001-33
17 Jun 2013
080712001-36
18 Jun 2013
090612001-01
18 Jun 2013
090612001-03
19 Jun 2013

 
 
MANUFACTURER:
 
Micro Typing Systems
Pompano Beach, FL
 
REASON:
 
Ortho-Clinical Diagnostics, Inc. (OCD) has received complaints of an incomplete foil seal for specific lots of ID-Micro Typing System™ Gel Cards.  They have isolated the issue to the lots listed above. Their investigation confirmed that some lots of MTS™ Anti-IgG Cards exhibited a weaker or a loose foil seal resulting in the potential for drying of the first microtube.  Using gel cards that exhibit drying in microtube(s) may cause false positive reactions leading to erroneous results. A positive result using MTS™ Anti-IgG Cards will lead to additional testing for confirmation of the result. Consignees are asked to follow the instructions as outlined in the Urgent Product Correction Notification.

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.