# FDA recall Z-1372-2022

> **Siemens Healthcare Diagnostics Inc** · Class II · device recall initiated 2022-06-01.

## 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

## Reason for recall

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

## Distribution

AL  CA  CO  FL  IA  ID  KS  NM  OK  TX

## Key facts

- **Recall number:** Z-1372-2022
- **Recalling firm:** Siemens Healthcare Diagnostics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-01
- **Report date:** 2022-07-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Norwood, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1372-2022

## Citation

> AI Analytics. FDA recall Z-1372-2022. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-1372-2022. Source: US FDA. Licensed CC0.

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