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Recall of MTS Anti-IgG Card
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DATE RECALL INITIATED: April 23, 2004 PRODUCT / LOT NUMBER / EXPIRATION DATE :
MTS Anti-IgG Card / 082203001-14 / 7/15/2004
MTS A/B/D Monoclonal and Reverse Grouping Card / 111903037-11 / 10/23/2004
MANUFACTURER:
Micro Typing Systems, Inc REASON: Micro Typing Systems, Inc. (MTS) has received reports of gel not present in one microtube of a limited number of cards. If gel is not present within a microtube, cells (agglutinated or non-agglutinated) will migrate to the bottom of the microtube following centrifugation. Test results using a defective microtube will appear negative. The impact of using a defective microtube is that serologically positive results would appear negative. As a precaution, all gel cards regardless of type or lot must be inspected prior to use. Consignees have been asked to contact the manufacturer for replacement product.
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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