Siemens epoc BGEM BUN Test Card Glucose Measurement Inaccuracy Recall
Siemens Healthcare Diagnostics recalls 3,201 epoc BGEM BUN Test Cards due to potential for inaccurately high glucose readings in low-glucose samples.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a diagnostic device with the potential to produce inaccurate glucose measurements that could result in missed diagnosis of hypoglycemia. Although no injuries or illnesses have been reported, the device failure creates a risk of harm to patients. This meets the rubric criterion for Score 3: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics Inc. is recalling 3,201 epoc BGEM BUN Test Cards due to a potential measurement inaccuracy. The affected lot numbers are 04-23003-60, 11-22337-60, 04-23034-40, 04-23059-50, 04-23059-60, and 04-23069-40.
The test cards have the potential to produce inaccurately high glucose results when testing samples with actual glucose levels on the lower end of the reportable range. This means the device may display a high glucose reading when a patient's actual glucose level is low.
The affected devices were distributed to healthcare facilities in multiple U.S. states (AL, AR, AZ, CA, CO, DC, DE, FL, IA, ID, IL, KS, KY, LA, MI, MN, MO, NC, ND, NH, NY, OH, OK, SC, SD, TX) and internationally in Canada, China, Colombia, Finland, India, Mexico, Norway, Sweden, United Arab Emirates, and Vietnam.
The recalled product
- Product
- epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 3,201
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 11-22337-60 (expiry 20-May-2023)
- 04-23034-40 (expiry 21-Jul-2023)
- 04-23059-50 (expiry 15-Aug-2023)
- 04-23059-60 (expiry 15-Aug-2023)
- and 04-23069-40 (expiry 25-Aug-2023)
Distribution
Part of a larger recall action
This product is one of 3 recalled by Siemens Healthcare Diagnostics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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