Vaccines, Blood & Biologics

URGENT PRODUCT CORRECTION NOTIFICATION-MTS™ Anti-IgG Cards

DATE NOTIFICATION INITIATED: November 5, 2012

Product Code
MTS084024

Product Name MTS™ Anti-IgG Card

Affected Lot No.Expiry Date
080712001-2407 Jun 2013
080712001-2507 Jun 2013
080712001-2610 Jun 2013
080712001-2710 Jun 2013
080712001-2811 Jun 2013
080712001-2911 Jun 2013
080712001-3013 Jun 2013
080712001-3114 Jun 2013
080712001-3214 Jun 2013
080712001-3317 Jun 2013
080712001-3618 Jun 2013
090612001-0118 Jun 2013
090612001-0319 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.

Page Last Updated: 08/21/2014
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