FDA (Devices) recall action 89740
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
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 is recalling Atellica CH Calcium_2 diagnostic reagent due to potential reagent carryover that could impact quality control, patient samples, and calibrator results. The recall affects approximately 2,395 units distributed globally and in the US.
Siemens Healthcare Diagnostics is recalling Atellica CH Fructosamine reagent (lots 211359, 211451) due to potential reagent carryover that could affect diagnostic test accuracy.
Siemens Healthcare Diagnostics recalls approximately 2,158 units of Atellica CH Lithium_2 reagent (Lot Numbers 110108, 110185, 110238, 110302) due to potential for reagent carryover affecting quality control results, patient samples, and calibrator results.
Siemens Healthcare is recalling Atellica CH Hemoglobin A1c reagent kits due to potential reagent carryover affecting quality control and patient test results. The issue may cause inaccurate diabetes monitoring measurements.