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
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 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 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
ArkansasCaliforniaDistrict of ColumbiaFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMinnesotaMissouriMississippiMontanaNorth CarolinaNorth 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: 10101018 UDI-DI Code: 00862011000307 Lot Numbers: 5549A 5566A 5588A 5606A 5612A
Where was it sold?
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
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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| Device | CLASS II | Accelerate PhenoTest BC kit recalled by Accelerate Diagnostics | Accelerate Diagnostics | Other Bacterial Contamination | 31 states |
| Device | CLASS II | Accelerate Pheno system, with Accelerate Pheno System recalled | Accelerate Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Accelerate PhenoTest BC kit recalled by Accelerate Diagnostics | Accelerate Diagnostics | Other Bacterial Contamination | 5 states |
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