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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90107

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

Open FDA event record

Event summary

Timeline bucket
April 17, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
PROTERIXBIO

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

ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number

Z-1058-2022
Recall number
Z-1058-2022
Initiated
April 17, 2022
Classification
Class II
Status
Terminated
Recalling firm
PROTERIXBIO
Quantity
640 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
FDA review concluded that the test is insufficiently supported by clinical performance data, and results reported may not have been accurate (false positives or false negatives).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

FDA review concluded that the test is insufficiently supported by clinical performance data, and results reported may not have been accurate (false positives or false negatives).

Code information

Lots were not coded. All product will be recalled.

Distribution pattern

Domestic distribution to CA CO FL IA MA MO NH NY OH OK TX VA