Accelerate Diagnostics Inc: 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.

Recall number

Z-1065-2019

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.

Status

Terminated

Initiated

2017-03-13

Posted

not on file

Terminated

2021-05-21

Reason

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

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: Support@axdx.com. EMEA Customer Service and Technical Support:: Direct: +34 93 220 4547, Email: Support.emea@axdx.com.

Quantity

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

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

PRH

Firm FEI

3010671651

Firm city

Tucson

Firm state

AZ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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