Recall Z-2970-2020— Siemens Healthcare Diagnostics Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics Inc, initiated 2020-08-28, terminated 2021-09-09. It names one FDA 510(k) clearance: K200107. Product: Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care SMN#/Model #: 10736382. Reason: Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for a delay in diagnosis of hyperglycemia or unnecessary treatment for hypoglycemia..
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-08-28
- Terminated
- 2021-09-09
- Firm location
- Norwood, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care SMN#/Model #: 10736382
Reason for recall
Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for a delay in diagnosis of hyperglycemia or unnecessary treatment for hypoglycemia.
Data sourced from openFDA. This site is unofficial and independent of the FDA.