Vaccines, Blood & Biologics
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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 / LOT NUMBER / EXPIRATION DATE:
Product Code | Product Name | Affected Lot No. | Expiry Date |
|---|---|---|---|
MTS080515 | MTS™ A/B/D Monoclonal and Reverse Grouping Card | 070312037-30 | 10 Jun 2013 |
070312037-32 | 11 Jun 2013 | ||
070312037-34 | 12 Jun 2013 | ||
070312037-35 | 12 Jun 2013 | ||
070312037-36 | 13 Jun 2013 | ||
091312037-02 | 17 Jun 2013 | ||
091312037-06 | 02 Jul 2013 | ||
MTS080017 | MTS™ A/B Monoclonal Grouping Card | 060612057-03 | 13 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.
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