CLASS II Device recall · Reported 2 May 2018 · FDA Enforcement Report

Accelerate PhenoTest BC kit recalled by Accelerate Diagnostics

Accelerate Diagnostics is recalling Accelerate PhenoTest BC kit, distributed in California, Delaware, Illinois, South Carolina, Texas. The recall was initiated on 14 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot numbers 2880A, 2885A, 2886A, and 2887A, all with exp. date of 9/18/2018.
Quantity recalled95 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-1529-2018
FDA event ID
79631
Recalling firm
Accelerate Diagnostics, Tucson, AZ
Classification
Class II
Status
Terminated
Recall initiated
14 Mar 2018
FDA classified
26 Apr 2018
Reported
2 May 2018
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Other Reasons

Timeline

14 Mar 2018Recall initiated by company
26 Apr 2018Classified by FDA+43 days
2 May 2018Published in enforcement report+6 days

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

Reason for recall

The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).

Product as listed by the FDA

Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.

Where it was distributed

Distributed to IL, TX, CA, SC, and DE.

CaliforniaDelawareIllinoisSouth CarolinaTexas

Questions about this recall

Is Accelerate PhenoTest BC kit recalled?

Yes. Accelerate Diagnostics recalled Accelerate PhenoTest BC kit on 14 Mar 2018. The recall is Class II and its status is Terminated. Recall number Z-1529-2018.

Why was it recalled?

The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).

Which lots are affected?

Lot numbers 2880A, 2885A, 2886A, and 2887A, all with exp. date of 9/18/2018.

Where was it sold?

Distributed to IL, TX, CA, SC, and DE.

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
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIAccelerate PhenoTest BC kit recalled by Accelerate DiagnosticsAccelerate DiagnosticsOther31 states
DeviceCLASS IIAccelerate PhenoTest BC kit recalled by Accelerate DiagnosticsAccelerate DiagnosticsOther31 states
DeviceCLASS IIAccelerate Pheno system, with Accelerate Pheno System recalledAccelerate DiagnosticsDevice MalfunctionNationwide

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