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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90432

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

Open FDA event record

Event summary

Timeline bucket
June 01, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Siemens Healthcare Diagnostics 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

epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood Product Siemens SMN#/Model #: 10736515

Z-1372-2022
Recall number
Z-1372-2022
Initiated
June 01, 2022
Classification
Class II
Status
Ongoing
Quantity
263 Boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.

Code information

UDI-DI: 00809708121860 Lot Number: 11-22005-50 Exp. Date: 22-June-2022

Distribution pattern

AL CA CO FL IA ID KS NM OK TX