Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 23, 2020
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
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 hy…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Siemens Healthcare Diagnostics Inc recalled Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of sa… - a moderate-severity action.
Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of sa… was recalled by Siemens Healthcare Diagnostics Inc in September 23, 2020. Reason: Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for…. Check the official notice for the remedy. Verify recall #Z-2970-2020 with the FDA Devices before acting.
The recall
Siemens Healthcare Diagnostics Inc issued this moderate-severity FDA Devices recall-Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for….
- Moderate
- severity level
- Class II
- classification
- September 23, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2970-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2970-2020) was formally reported on September 23, 2020, with the manufacturer initiating the action on August 28, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Siemens Healthcare Diagnostics Inc is listed as the recalling firm, operating out of Norwood, MA. Federal records list the affected scope as 463 boxes (50 test cards/box ).
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Nationwide Foreign: Canada. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
463 boxes (50 test cards/box )
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2970-2020 |
| Date reported | September 23, 2020 |
| Date initiated | August 28, 2020 |
| Recalling firm | Siemens Healthcare Diagnostics Inc |
| Firm location | Norwood, MA |
| Affected scope | 463 boxes (50 test cards/box ) |
| Distribution | Nationwide Foreign: Canada |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2970-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Siemens Healthcare Diagnostics Inc. Units affected: 463 boxes (50 test cards/box ).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 23, 2020. Severity: Moderate. Recall number: Z-2970-2020.
Where was the recalled product distributed? ▼
Distribution: Nationwide Foreign: Canada.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2970-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 23, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.