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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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.

 

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448