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: 10102018 UDI-DI Code: 00862011000369 Lot Numbers: 5559A 5556A 5555A 5554A 5553A 5551A 5550A 5548A 5546A 5557A 5558A 5560A 5561A 5562A 5563A 5564A 5567A 5568A 5570A 5571A 5572A 5574A 5578A 5579A 5580A 5583A 5577A 5576A 5581A 5582A 5585A 5586A 5587A 5589A 5590A 5591A 5592A 5594A 5595A 5596A 5597A 5598A 5599A 5601A 5602A 5603A 5604A 5607A 5608A 5610A 5611A 5613A 5614A

Quantity recalled7,160 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-0346-2023
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 Bacterial Contamination
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 10102018

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

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: 10102018 UDI-DI Code: 00862011000369 Lot Numbers: 5559A 5556A 5555A 5554A 5553A 5551A 5550A 5548A 5546A 5557A 5558A 5560A 5561A 5562A 5563A 5564A 5567A 5568A 5570A 5571A 5572A 5574A 5578A 5579A 5580A 5583A 5577A 5576A 5581A 5582A 5585A 5586A 5587A 5589A 5590A 5591A 5592A 5594A 5595A 5596A 5597A 5598A 5599A 5601A 5602A 5603A 5604A 5607A 5608A 5610A 5611A 5613A 5614A

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

Other products in this recall event

1 other product · FDA event 91075

This product is part of a recall event; the main page for the event is Accelerate PhenoTest BC kit recalled by Accelerate Diagnostics.

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

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 Bacterial Contamination	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 Bacterial Contamination	5 states

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