Z-1529-2018Class II

Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ...

Name: Z-1529-2018 Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ...
Creator: Accelerate Diagnostics Inc
Published: 2018-03-14
License: https://open.fda.gov/license/

Accelerate Diagnostics, Inc. / initiated 2018-03-14 / Terminated

FDA source

Accelerate Diagnostics Inc began a recall of Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended... on 2018-03-14. FDA classified it as Class II and gives the reason as "The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1529-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-14
Posted: 2018-04-26
Terminated: 2023-01-17
Recalling firm: Accelerate Diagnostics, Inc.
Product: 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.
Product code: PRH Positive Blood Culture Identification And Ast Kit
Reason for recall: The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).
FDA root cause: Under Investigation by firm
Action: The recalling firm contacted all customers on 3/14/2018 via telephone, and a follow-up e-mail was also sent containing a technical bulletin #TB000079, entitled Product Correction Notice, dated March 14, 2018. The notice identified the affected devices and the reason for the recall. Customers were asked to please discontinue use of and dispose of all remaining kits from the affected lots, and document the disposal by completing the 'Certificate of Kit Disposal.' Replacement kits will be provided.
Quantity in commerce: 95 kits
Distribution: Distributed to IL, TX, CA, SC, and DE.
Product codes and lots: Lot numbers 2880A, 2885A, 2886A, and 2887A, all with exp. date of 9/18/2018.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1529-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1529-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-26

Product code PRH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)