FDA (Devices) recall action 88792
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.
Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.
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 has recalled approximately 1,193 Atellica IM 1300 analyzers due to reagent overflow that occurs at altitudes above 350 meters, causing diagnostic test errors.
Siemens Healthcare Diagnostics is recalling Atellica IM 1600 analyzers that may leak reagent when located at altitudes above 350 meters, potentially causing testing errors.