Class II — Siemens Healthcare Diagnostics Inc
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support. |
| Product | 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 |
| Quantity | 263 Boxes |
| Distribution | AL CA CO FL IA ID KS NM OK TX |
| Initiated | 2022-06-01 |
| Classified | 2022-07-12 |
| Recall number | Z-1372-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Healthcare Diagnostics Inc (Z-1372-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90432/
Alerts for SIEMENS HEALTHCARE DIAGNOSTICS INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.