# FDA recall Z-2970-2020

> **Siemens Healthcare Diagnostics Inc** · Class II · device recall initiated 2020-08-28.

## Product

Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care  SMN#/Model #:  10736382

## Reason for recall

Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for a delay in diagnosis of hyperglycemia or unnecessary treatment for hypoglycemia.

## Distribution

Nationwide  Foreign: Canada

## Key facts

- **Recall number:** Z-2970-2020
- **Recalling firm:** Siemens Healthcare Diagnostics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-28
- **Report date:** 2020-09-23
- **Termination date:** 2021-09-09

- **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-2970-2020

## Citation

> AI Analytics. FDA recall Z-2970-2020. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-2970-2020. Source: US FDA. Licensed CC0.

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