CLASS II ONGOING Device recall · Reported 20 Jul 2022 · FDA Enforcement Report
epoc BGEM Test Card 25 Test Cards/box recalled
Siemens Healthcare Diagnostics is recalling epoc BGEM Test Card 25 Test Cards/box, distributed in 8 states. The recall was initiated on 1 Jun 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1372-2022
- FDA event ID
- 90432
- Recalling firm
- Siemens Healthcare Diagnostics, Norwood, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Jun 2022
- FDA classified
- 12 Jul 2022
- Reported
- 20 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 1 Jun 2022 | Recall initiated by company | |
| 12 Jul 2022 | Classified by FDA | +41 days |
| 20 Jul 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.
Product as listed by the FDA
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
Where it was distributed
AL CA CO FL IA ID KS NM OK TX
Questions about this recall
Why was it recalled?
Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.
Which lots are affected?
UDI-DI: 00809708121860 Lot Number: 11-22005-50 Exp. Date: 22-June-2022
Where was it sold?
AL CA CO FL IA ID KS NM OK TX
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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