Z-1065-2019Class II

Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B

Name: Z-1065-2019 Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B
Creator: Accelerate Diagnostics Inc
Published: 2017-03-13
License: https://open.fda.gov/license/

Accelerate Diagnostics, Inc. / initiated 2017-03-13 / Terminated / root cause: software

FDA source

Accelerate Diagnostics Inc began a recall of Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product Usage: The Accelerate Pheno system is intended to measure... on 2017-03-13. FDA classified it as Class II and gives the reason as "Rare isolates of Enterobacteriaceae may generate a susceptible meropenem Minimum Inhibitory Concentration (MIC) using the affected device and a resistant result by broth microdilution. In order to mitigate any risk...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1065-2019
Classification: Class II
Status: Terminated
Initiated: 2017-03-13
Posted: 2019-03-27
Terminated: 2021-05-21
Recalling firm: Accelerate Diagnostics, Inc.
Product: Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product Usage: The Accelerate Pheno system is intended to measure signal intensity of fluorescent probes bound to nucleic acid in target and non-target organisms and to take time-lapse dark-field images of immobilized growing bacterial cells when used with Accelerate PhenoTest kits.
Product code: PRH Positive Blood Culture Identification And Ast Kit
Reason for recall: Rare isolates of Enterobacteriaceae may generate a susceptible meropenem Minimum Inhibitory Concentration (MIC) using the affected device and a resistant result by broth microdilution. In order to mitigate any risk associated with these rare isolates, the firm has implemented an Expert Rule that suppresses the meropenem result for isolates that display a profile consistent with those that generated a false-susceptible result. The firm has responded to this risk by implementing a set of suppression rules, in a software update, to prevent incorrect results.
Root cause tag: software
FDA root cause: Software design
Action: On 03/13/2017, customers were notified via phone of the potential risk of very major errors with meropenem for systems that have not been equipped with the most recent software update. TB000037, dated 03/16/17, was sent to customers after product launch. TB000082 and TB000083, dated 06/08/2018, were sent to customers that ran patient samples prior to installing the 1.3.1 PSW000012C patch. Starting on 01/25/19, Medical Device Correction notices were sent to customers, which provided a secondary notification of the suppression rules previously provided in TB000082 and TB000083. Customers were asked to do the following: (1) If you have not already done so, please contact customer support to schedule installation of the latest software version on your system. (2) Retrospectively review affected runs, specifically meropenem results. (3) As an interim measure, and until the latest software version is installed, you should review meropenem results obtained with the original software and apply the AST suppression rules (as noted in technical bulletins TB000082 and TB000083) to those results. Customers were asked to compete and return an acknowledgement form to indicate that they have received the correction notice and taken appropriate action. North America Customer Service and Technical Support: Toll free: +1 (888) 586 2939 opt. 4, Direct: +1 (520) 365 3100, Email: [email protected]. EMEA Customer Service and Technical Support:: Direct: +34 93 220 4547, Email: [email protected].
Quantity in commerce: 81
Distribution: Worldwide Distribution - US Nationwide North America and Middle East US: TX, IL, TN, GA, CA, AR, MD, VA, Washington DC, IA, PA, NY, WA, and MO. OUS (Foreign): UK, Spain, Italy, and Germany
Product codes and lots: REF: 10401008. Serial Numbers: 1324, 1325, 1431, 1432, 1084, 1087, 1367, 1362,1363,1615, 1616, 1358, 1359, 1453, 1354, 1357, 1599, 1176, 1178, 1353, 1356, 1576, 1577, 1578, 1322, 1323, 1454, 1594, 1598, 1288, 1290, 1688, 1690, 1691, 1694, 1798, 1799, 1800, 1801, 1135, 1151, 1326, 1327, 1477, 1478, 1479, 1480, 1619, 1620, 1617, 1618, 1489, 1501, 1687, 1573, 1574, 1144, 1145, 1247, 1249 ,1264, 1277, 1265, 1277, 1278, 1381, 1150, 1286, 1148, 1149, 1254, 1260, 1397, 1542, 1458, 1517, 1231, 1238, 1282, 1284, 1389

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1065-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1065-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-03	2019-03-27

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)