Medical device recalls Moderate risk

Advance Dx, Inc. recalls Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity…

Recall date
July 6, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2237-2021
FDA classification
Class II
Brand / firm
Advance Dx, Inc.
Sold / distributed
U.S. Nationwide distribution in the states of MD and NC.

Why it was recalled

Due to high glucose test results when using the blood collection cards.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity 500 Cards and Foil Bags REF CMT01/F02 IFU: Advance Dx 100 SSE(Serum Separating Extraction) Technology BLOOD COLLECTION INSTRUCTIONS

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