FDA Device recall Z-1372-2022
epoc BGEM Test Card 25 Test Cards/box
- FDA Device
- Class II
- ongoing
- Published 2022-07-20
On 2022-07-20 the FDA classified a Class II recall of epoc BGEM Test Card 25 Test Cards/box by Siemens Healthcare Diagnostics, citing discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1372-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-01 |
| Published | 2022-07-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | AL, CA, CO, FL, IA, ID, KS, NM, OK, TX |
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.
Identifiers
| code_info | UDI-DI: 00809708121860 Lot Number: 11-22005-50 Exp. Date: 22-June-2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1372-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.