Z-2970-2020Class II

Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized...

Name: Z-2970-2020 Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized...
Creator: Siemens Healthcare Diagnostics Inc
Published: 2020-08-28
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2020-08-28 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics Inc began a recall of Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or... on 2020-08-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2970-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-28
Posted: 2020-09-15
Terminated: 2021-09-09
Recalling firm: Siemens Healthcare Diagnostics Inc.
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
Product code: CGA Glucose Oxidase, Glucose
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Siemens issued Urgent Medical Device Correction letter on August 28, 2020 via Federal Express stating the reason for recall communication letter informs customers of the issue and, health risk and action take: Please dispose any inventory of test card lot 01-20095-10 currently in your possession in accordance with local and state disposal requirements. You may request free of charge replacement product from your local Siemens or distributor office. Please review your inventory of these products and assess your laboratorys replacement needs. Please use epoc BGEM Test Card from another unaffected lot. Complete and return the Field Correction Effectiveness Check and Product Replacement Form attached to this letter. Please retain this letter with your laboratory records and forward it to those who may have received this product. Questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.
Quantity in commerce: 463 boxes (50 test cards/box )
Distribution: Nationwide Foreign: Canada
Product codes and lots: Lot Number: 01-20095-10

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2970-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2970-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-23	2020-09-14

Product code CGA

K200107Class IIepoc Blood Analysis SystemEpocal, Inc. / cleared 2020-06-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)