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|
Micro Typing Systems
Pompano Beach, FL
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.
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.