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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
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002