Vaccines, Blood & Biologics

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.


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
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.