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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93626

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

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Event summary

Timeline bucket
October 25, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
PHASE SCIENTIFIC INTERNATIONAL LIMITED

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

INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040

Z-0738-2024
Recall number
Z-0738-2024
Initiated
October 25, 2023
Classification
Class II
Status
Ongoing
Quantity
360 Kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
COVID-19 rapid antigen at home tests were released with an incorrect expiration date of 05 April 2024 when the correct expiration should be 21 February 2024. Expired tests could produce invalid or inaccurate results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Incorrect or no expiration date

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

COVID-19 rapid antigen at home tests were released with an incorrect expiration date of 05 April 2024 when the correct expiration should be 21 February 2024. Expired tests could produce invalid or inaccurate results.

Code information

Lot: 22S0388-R01, Exp: 05-Apr-2024

Distribution pattern

US Nationwide distribution including in the states of CA, NY, VT, WA, OH, MD , NJ, PA, MS, NC, AL, MI, MA, DE, GA, TX, OR, MO , WI , ME, IL, VA, CO, NM, NH, LA, KY, DC, MN, MO, FL, AR, MD, TN, UT, WY, SC, WI, CT, KS, SD.