Medical DeviceSep 21, 2016
T2 Biosystems T2Candida¿Cartridges recall — FDA Z-2795-2016
Elevated levels of invalid results.
Class IIFDA: TerminatedT2 Biosystems Inc.
Recall history in this database
Classification mix: Class II: 1.
Understanding this recall history
This page summarizes recall records in which the official source identifies T2 Biosystems Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.