Medical DeviceJul 19, 2017
AMS Diagnostics Medica ISE Module Calibrant A recall — FDA Z-2725-2017
Lot was not functioning properly and not exhibiting the correct physical properties.
Class IIIFDA: OngoingAMS Diagnostics, LLC
Recall history in this database
Classification mix: Class III: 1.
Understanding this recall history
This page summarizes recall records in which the official source identifies AMS Diagnostics, LLC 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.