PlainRecordsepoc BGEM BUN Test Card with epoc Host SW v3.37.3… and 2 more products
- Reason
- There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
- Status
- Ongoing
- Distribution
- 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
- Enforcement report date
- Sept. 6, 2023
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): 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)
- Status
- Ongoing (FDA has not recorded a termination for this recall; FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Siemens Healthcare Diagnostics Inc
- Reason
- There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
- Distribution pattern
- 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 the record says about this device
A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.
“There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.”epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1, FDA enforcement report, 2023-09-06. The caption is the record's own words.
A generic device, not the product. The mark follows the record's own words.
If the drawing and the record's words differ, the words govern. A drawing is chosen by rules and an AI reading of the record and can miss what it means; report one with the form below.
FDA device name: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Distributed in (FDA's record): Alabama Arizona Arkansas California Colorado Delaware District of Columbia Florida Idaho Illinois Iowa Kansas Kentucky Louisiana Michigan Minnesota Missouri New Hampshire New York North Carolina North Dakota Ohio Oklahoma South Carolina South Dakota Texas
3 products in this recall
epoc BGEM BUN Test Card with epoc Host SW v3.37.3…
- Product
- epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
- Quantity
- 3201 ea
- Codes and lots
- UDI-DI: 00809708121860 Siemens Material Number: 10736515 Lots: 04-23003-60 (expiry 20-Jun-2023), 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)
- Recall started
- June 1, 2023
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- Consignees were notified via an Urgent Medical Device Correction letter beginning June 5, 2023. Consignees were informed of the issue and were provided a workaround and actions to take. The next sensor configuration/software version, sensor configuration 42.1/epoc Host SW v3.38.2 /epoc NXS SW v4.11.11, is available to customers in Siemens Healthineers Document Library or the epoc Live Update Service (eLUS). This next sensor configuration, 42.1, mitigates the issue.
- Recall number
- Z-2476-2023
epoc BGEM Crea Test Card with epoc Host SW v3.37.3…
- Product
- epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
- Quantity
- 473 ea
- Codes and lots
- UDI-DI: 00809708072254 Siemens Material Number: 10736382 Lots: 03-23002-60 (expiry 19-Jun-2023) and 03-23056-50 (expiry 12-Aug-2023)
- Recall started
- June 1, 2023
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- Consignees were notified via an Urgent Medical Device Correction letter beginning June 5, 2023. Consignees were informed of the issue and were provided a workaround and actions to take. The next sensor configuration/software version, sensor configuration 42.1/epoc Host SW v3.38.2 /epoc NXS SW v4.11.11, is available to customers in Siemens Healthineers Document Library or the epoc Live Update Service (eLUS). This next sensor configuration, 42.1, mitigates the issue.
- Recall number
- Z-2477-2023
epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3…
- Product
- epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
- Quantity
- 348 ea
- Codes and lots
- UDI-DI: 00630414243788 Siemens Material Number: 10736516 Lots: 04-23043-51 (expiry 30-Jul-2023)
- Recall started
- June 1, 2023
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- Consignees were notified via an Urgent Medical Device Correction letter beginning June 5, 2023. Consignees were informed of the issue and were provided a workaround and actions to take. The next sensor configuration/software version, sensor configuration 42.1/epoc Host SW v3.38.2 /epoc NXS SW v4.11.11, is available to customers in Siemens Healthineers Document Library or the epoc Live Update Service (eLUS). This next sensor configuration, 42.1, mitigates the issue.
- Recall number
- Z-2478-2023
This recall among the others
- FDA's enforcement report came 97 days after the firm started the recall. For half of the 835 FDA medical device recall events reported in 2023 with a start date, it took 51 days or fewer (by year).
- Siemens Healthcare Diagnostics: 50 other recalls or notices on this site in the three years before this one (from Sept. 6, 2020).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement reports, recall numbers Z-2476-2023, Z-2477-2023, Z-2478-2023. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-2476-2023, Sept. 6, 2023. "epoc BGEM BUN Test Card with epoc Host SW v3.37.3… and 2 more products." PlainRecords, https://plainrecords.com/recall/device/z-2476-2023/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections