epoc BGEM Test Card 25 Test Cards/box. In vitro recall
epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated…
Why was epoc BGEM Test Card 25 Test Cards/box. In vitro recalled?
Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00809708121860 Lot Number: 11-22005-50 Exp. Date: 22-June-2022
- Product
- epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated…
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Quantity
- 263 Boxes
- Distribution
- AL CA CO FL IA ID KS NM OK TX
- Recall date
- July 20, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)