FDA (Devices) recall action 92537
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Siemens Healthcare Diagnostics recalls 3,201 epoc BGEM BUN Test Cards due to potential for inaccurately high glucose readings in low-glucose samples.
Siemens Healthcare is recalling epoc BGEM Crea Test Cards that may produce inaccurate glucose readings in lower-range samples. 473 units were distributed to US facilities and international locations. No injuries reported.
Siemens Healthcare Diagnostics is recalling epoc BGEM Test Cards for veterinary use due to potential inaccurate glucose results in lower-range samples. Affected units may report artificially elevated readings.