Vaccines, Blood & Biologics

URGENT PRODUCT CORRECTION NOTIFICATION - MTS™ A/B/D Monoclonal and Reverse Grouping Cards & MTS™ A/B Monoclonal Grouping Cards

DATE NOTIFICATION INITIATED: November 5, 2012

Product Code
MTS080515

Product Name
MTS™ A/B/D Monoclonal and Reverse Grouping Card

Affected Lot No.Expiry Date
070312037-3010 Jun 2013
070312037-3211 Jun 2013
070312037-3412 Jun 2013
070312037-3512 Jun 2013
070312037-3613 Jun 2013
091312037-0217 Jun 2013
091312037-0602 Jul 2013

Product Code
MTS080017

Product Name
MTS™ A/B Monoclonal Grouping Card

Affected Lot No.Expiry Date
060612057-0313 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 MTS Gel Cards exhibited a weaker or a loose foil seal resulting in the potential for drying of the first microtube. Consignees are asked to immediately discontinue using and discard remaining inventory of the MTS Gel Cards listed above.


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.

Page Last Updated: 08/21/2014
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