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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 3 of 3 Results
510(K) Number: K111150
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Product Description
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Recall
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FDA Recall
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Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distributor Produc... 2 07/29/2013 Steritec Products Mfc. Co., Inc.
Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/25, Distributor Product... 2 07/29/2013 Steritec Products Mfc. Co., Inc.
Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25, Distributor Pr... 2 07/29/2013 Steritec Products Mfc. Co., Inc.
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