CLASS II ONGOING Device recall · Reported 7 Dec 2022 · FDA Enforcement Report

Accelerate PhenoTest BC kit recalled by Accelerate Diagnostics

Accelerate Diagnostics is recalling Accelerate PhenoTest BC kit, distributed in 31 states. The recall was initiated on 17 Oct 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number: 10101018 UDI-DI Code: 00862011000307 Lot Numbers: 5549A 5566A 5588A 5606A 5612A

Quantity recalled200 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0345-2023
FDA event ID: 91075
Recalling firm: Accelerate Diagnostics, Tucson, AZ
Classification: Class II
Status: Ongoing
Recall initiated: 17 Oct 2022
FDA classified: 30 Nov 2022
Reported: 7 Dec 2022
Type: Voluntary: Firm initiated
Customers notified by: Other
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

17 Oct 2022	Recall initiated by company
30 Nov 2022	Classified by FDA	+44 days
7 Dec 2022	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp.

Product as listed by the FDA

Accelerate PhenoTest BC kit REF 10101018

Where it was distributed

U.S.: AR, CA, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, MS, MT, NC, ND, NJ, NY, OH, PA, RI, SC, TN, TX, VA, WA, and WV. O.U.S.: Germany, Italy, Kuwait, Latvia, Poland, Portugal, Romania, Saudi Arabia, Spain, and United Arab Emirates

Arkansas California District of Columbia Florida Georgia Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Minnesota Missouri Mississippi Montana North Carolina North Dakota

Questions about this recall

Is Accelerate PhenoTest BC kit recalled?

Yes. Accelerate Diagnostics recalled Accelerate PhenoTest BC kit on 17 Oct 2022. The recall is Class II and its status is Ongoing. Recall number Z-0345-2023.

Why was it recalled?

Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp.

Which lots are affected?

Part Number: 10101018 UDI-DI Code: 00862011000307 Lot Numbers: 5549A 5566A 5588A 5606A 5612A

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Accelerate Diagnostics

All 4

Reported	Class	Recall	Company	Reason	Where
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

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