The Recall Desk
HighFDA (Devices)·Z-2476-2023·Announced 2023-09-06

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.

What this means for you

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
Category
Medical Device — Diagnostic / Blood Glucose Monitoring
Hazard
  • measurement-error
  • inaccurate-glucose-reading

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

Distributed in 26 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

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