Advance Dx, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2237-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 6, 2021

Date Posted: August 18, 2021

Recall Number: Z-2237-2021

Event ID: 88281

Reason for Recall:

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

Status: Terminated

Product Quantity: 179,750 cards

Code Information:

Product Catalog Number: CMT01 GTIN: 1061C010890976 Lot Number: PPD02102 V6

Distribution Pattern:

U.S. Nationwide distribution in the states of MD and NC.

Voluntary or Mandated:

Voluntary: Firm initiated