FDA (Devices) recall action 79074
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.
Complaints have been received concerning questionable results on analyzers due to customers utilizing sample 13 mm tubes without tube adapters.
Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 sample tubes without tube adapters.
Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 mm sample tubes without tube adapters.
The agency’s own wording, quoted from the enforcement report.
Roche Diagnostics is recalling Modular E 170 Analyzers because using 13 mm sample tubes without adapters may cause questionable test results.
Roche Diagnostics is recalling cobas e 601 Immunoassay Analyzers because complaints were received regarding questionable results caused by the use of 13 sample tubes without tube adapters.
Roche Diagnostics is recalling cobas e 411 Immunoassay Analyzers because using 13 mm sample tubes without adapters may cause questionable results.