Z-1372-2022 Class II Ongoing
FDA device recall Z-1372-2022 was initiated by Siemens Healthcare Diagnostics Inc on Jun 1, 2022 and is designated Class II. Reason for recall: Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support. The recall status is ongoing. Affected quantity: 263 Boxes.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 20, 2022
- Initiation Date
- Jun 1, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 263 Boxes
Product Description
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 Pattern
AL CA CO FL IA ID KS NM OK TX
Code Information
UDI-DI: 00809708121860 Lot Number: 11-22005-50 Exp. Date: 22-June-2022
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1372-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026