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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

No recalls linked.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2023-08-03NAINo action indicatedBio-Rad Laboratories, Inc.0
2023-08-03NAINo action indicatedBio-Rad Laboratories, Inc.0
2021-07-15VAIVoluntary action indicatedBio-Rad Laboratories, Inc.0
2019-06-04NAINo action indicatedExact Diagnostics0
2017-08-17NAINo action indicatedBio-Rad Laboratories, Inc.0
2017-08-17NAINo action indicatedBio-Rad Laboratories, Inc.0
2017-05-26NAINo action indicatedBio-Rad Laboratories, Inc.0
2017-05-26NAINo action indicatedBio-Rad Laboratories, Inc.0
2017-05-23NAINo action indicatedBio-Rad Laboratories, Inc0
2017-05-23NAINo action indicatedBio-Rad Laboratories, Inc0
2017-05-22NAINo action indicatedBio-Rad Laboratories, Inc0
2017-05-22NAINo action indicatedBio-Rad Laboratories, Inc0
2016-04-14NAINo action indicatedBio-Rad Laboratories GmbH0
2016-02-25OAIOfficial action indicatedBio-Rad Laboratories, Inc.1
2016-02-25OAIOfficial action indicatedBio-Rad Laboratories, Inc.1
2015-09-03WLWarning LetterBio-Rad Laboratories GmbH—
2015-01-22OAIOfficial action indicatedBio-Rad Laboratories GmbH7
2013-12-04NAINo action indicatedBio-Rad Laboratories, Inc0
2013-12-04NAINo action indicatedBio-Rad Laboratories, Inc0
2013-12-02NAINo action indicatedBio-Rad Laboratories, Inc0
2013-12-02NAINo action indicatedBio-Rad Laboratories, Inc0
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