Vaccines, Blood & Biologics
Recall of MTS Anti-IgG Card and MTS A/B/D Monoclonal and Reverse Grouping Card-Micro Typing Systems, Inc
DATE RECALL INITIATED:
April 23, 2004
PRODUCT / LOT NUMBER / EXPIRATION DATE:
MTS Anti-IgG Card / 082203001-14 / 7/15/2004
(Microtube # 1 from left to right with the barcode facing forward)
MTS A/B/D Monoclonal and Reverse Grouping Card / 111903037-11 / 10/23/2004
(Anti-D Microtube)
MANUFACTURER:
Micro Typing Systems, Inc
Pompano Beach, FL
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.







