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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90013

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

Open FDA event record

Event summary

Timeline bucket
April 06, 2022
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
MESA BIOTECH, 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

Accula SARS-CoV-2 Test, REF: COV4100

Z-1009-2022
Recall number
Z-1009-2022
Initiated
April 06, 2022
Classification
Class I
Status
Ongoing
Recalling firm
MESA BIOTECH, INC
Quantity
6162

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.

Code information

UDI/DI: B540COV41000; P22006-026, P22010-021, P22024-023, P22024-030, P22026-006, P22026-012, P22026-016 , P22010-001, P22010-030, P22024-026, P22024-032, P22026-007, P22026-013, P22026-017 , P22010-017, P22010-032, P22024-027, P22026-002, P22026-008, P22026-014, P22026-019 , P22010-019, P22024-021, P22024-028, P22026-004, P22026-009, P22026-015, P22032-011

Distribution pattern

US Nationwide distribution in the states of CA, TX, MA, NY, FL, NC, NJ, GA, CO, HI, PA, WA, NY, VA, MD, KY, WI, IL, PR, ND, MI, TN, AZ, UT.

Field note

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