CLASS II ONGOING Device recall · Reported 6 Sep 2023 · FDA Enforcement Report
epoc BGEM Crea Test Card with epoc Host SW v3.37.3 recalled
Siemens Healthcare Diagnostics is recalling epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor, distributed in 26 states. The recall was initiated on 1 Jun 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2477-2023
- FDA event ID
- 92537
- Recalling firm
- Siemens Healthcare Diagnostics, Norwood, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Jun 2023
- FDA classified
- 28 Aug 2023
- Reported
- 6 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 1 Jun 2023 | Recall initiated by company | |
| 28 Aug 2023 | Classified by FDA | +88 days |
| 6 Sep 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Where it was distributed
US distribution to 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, and TX OUS distribution to Canada, China, Colombia, Finland, India, Mexico, Norway, Sweden, United Arab Emirates, and Vietnam
AlabamaArkansasArizonaCaliforniaColoradoDistrict of ColumbiaDelawareFloridaIowaIdahoIllinoisKansasKentuckyLouisianaMichiganMinnesotaMissouriNorth CarolinaNorth DakotaNew Hampshire
Questions about this recall
Why was it recalled?
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
Which lots are affected?
UDI-DI: 00809708072254 Siemens Material Number: 10736382 Lots: 03-23002-60 (expiry 19-Jun-2023) and 03-23056-50 (expiry 12-Aug-2023)
Where was it sold?
US distribution to 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, and TX OUS distribution to Canada, China, Colombia, Finland, India, Mexico, Norway, Sweden, United Arab Emirates, and Vietnam
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 92537| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | epoc BGEM Test Card (BUN & TCO2),Veterinary recalled | Siemens Healthcare Diagnostics | Device Malfunction | 26 states | |
| CLASS II | epoc BGEM BUN Test Card with epoc Host SW v3.37.3 recalled | Siemens Healthcare Diagnostics | Device Malfunction | 26 states |
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