Accelerate Diagnostics recalls

Accelerate Diagnostics has 4 recalls on record with the FDA and USDA, the earliest in 2018 and the latest reported on 7 Dec 2022. 2 are still ongoing.

Total recalls4since 2018

Last 12 months0reported

Class I00% of total

Ongoing2latest 7 Dec 2022

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 4 100%Class III 0 0%

Why accelerate diagnostics is recalled

Other Reasons375%
Device Malfunction125%

Product types

Other Medical Devices250%
Test Kits & Diagnostics250%

By year

2022250%
2019125%
2018125%

Ongoing accelerate diagnostics recalls

2 active

Reported	Class	Recall	Company	Reason	Where
7 Dec 2022Device	CLASS II	Accelerate PhenoTest BC kit recalled by Accelerate Diagnostics	Accelerate Diagnostics	Other	31 states
7 Dec 2022Device	CLASS II	Accelerate PhenoTest BC kit recalled by Accelerate Diagnostics	Accelerate Diagnostics	Other	31 states

All accelerate diagnostics recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
7 Dec 2022Device	CLASS II	Accelerate PhenoTest BC kit recalled by Accelerate Diagnostics	Accelerate Diagnostics	Other	31 states
7 Dec 2022Device	CLASS II	Accelerate PhenoTest BC kit recalled by Accelerate Diagnostics	Accelerate Diagnostics	Other	31 states
3 Apr 2019Device	CLASS II	Accelerate Pheno system, with Accelerate Pheno System recalled	Accelerate Diagnostics	Device Malfunction	Nationwide
2 May 2018Device	CLASS II	Accelerate PhenoTest BC kit recalled by Accelerate Diagnostics	Accelerate Diagnostics	Other	5 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.