Exact FDA event identifier

Event 88281

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket: July 06, 2021
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Advance Dx, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-2237-2021

Recall number: Z-2237-2021
Initiated: July 06, 2021
Classification: Class II
Status: Terminated
Recalling firm: Advance Dx, Inc.
Quantity: 179,750 cards

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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