---
title: "epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the qua... — FDA record Z-1372-2022 | Is It on Recall"
description: "Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support."
url: https://isitonrecall.com/recall/fda-device-z-1372-2022-epoc-bgem-test-card-25-test-cards-box-in-vitro-diagnostic-device-for-the-quantitative-testing-of-sam/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparini... — FDA record Z-1372-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jun 1, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.
- **Classification**: Class II
- **Recalling firm**: Siemens Healthcare Diagnostics Inc
- **Quantity**: 263 Boxes
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1372-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1372-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI-DI: 00809708121860 Lot Number: 11-22005-50 Exp. Date: 22-June-2022 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

AL CA CO FL IA ID KS NM OK TX

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Alabama](https://isitonrecall.com/state/alabama/)
- [California](https://isitonrecall.com/state/california/)
- [Colorado](https://isitonrecall.com/state/colorado/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Iowa](https://isitonrecall.com/state/iowa/)
- [Idaho](https://isitonrecall.com/state/idaho/)
- [Kansas](https://isitonrecall.com/state/kansas/)
- [New Mexico](https://isitonrecall.com/state/new-mexico/)
- [Oklahoma](https://isitonrecall.com/state/oklahoma/)
- [Texas](https://isitonrecall.com/state/texas/)

## Dates in the source

- **Report date**: Jul 20, 2022
- **Recall initiation date**: Jun 1, 2022
- **Center classification date**: Jul 12, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1372-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Siemens Healthcare Diagnostics, Inc. records](https://isitonrecall.com/brand/siemens-healthcare-diagnostics-inc/)