RecallRadar

FDA Device recall Z-2237-2021

Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity 500 Cards and Foil B…

On 2021-08-18 the FDA classified a Class II recall of Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity 500 Cards and Foil B… by Advance Dx, citing due to high glucose test results when using the blood collection cards.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2237-2021
ClassificationClass II
Statusterminated
Initiated2021-07-06
Published2021-08-18
Last updated2026-09-13 11:56 UTC
CompanyAdvance Dx
DistributionUS

Product

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

Reason

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2237-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.