FDA (Devices) recall action 83516
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent (LN 2P56) may result infalsely elevated lithium patient 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.
Sentinel CH SpA is recalling 15,919 MULTIGENT Lithium reagent kits due to a potential carryover issue that may cause falsely elevated patient results.
Sentinel CH SpA is recalling Alinity c Lithium Reagent Kits due to a potential carryover issue that may result in falsely elevated lithium patient results.