CLASS II Device recall · Reported 3 Apr 2019 · FDA Enforcement Report

Accelerate Pheno system, with Accelerate Pheno System recalled

Accelerate Diagnostics is recalling Accelerate Pheno system, with Accelerate Pheno System, distributed nationwide in the US. The recall was initiated on 13 Mar 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF: 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

Quantity recalled81

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-1065-2019
FDA event ID: 82216
Recalling firm: Accelerate Diagnostics, Tucson, AZ
Classification: Class II
Status: Terminated
Recall initiated: 13 Mar 2017
FDA classified: 27 Mar 2019
Reported: 3 Apr 2019
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Device Malfunction
Device type: Test Kits & Diagnostics

Timeline

13 Mar 2017	Recall initiated by company
27 Mar 2019	Classified by FDA	+744 days
3 Apr 2019	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

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Arkansas California District of Columbia Georgia Iowa Illinois Maryland Missouri New York Pennsylvania Tennessee Texas Virginia Washington

Stores named: Target

Questions about this recall

Is Accelerate Pheno system, with Accelerate Pheno System recalled?

Yes. Accelerate Diagnostics recalled Accelerate Pheno system, with Accelerate Pheno System on 13 Mar 2017. The recall is Class II and its status is Terminated. Recall number Z-1065-2019.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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

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

Reported	Class	Recall	Company	Reason	Where
7 Dec 2022Device	CLASS II	Accelerate PhenoTest BC kit recalled by Accelerate Diagnostics	Accelerate Diagnostics	Other	31 states
7 Dec 2022Device	CLASS II	Accelerate PhenoTest BC kit recalled by Accelerate Diagnostics	Accelerate Diagnostics	Other	31 states
2 May 2018Device	CLASS II	Accelerate PhenoTest BC kit recalled by Accelerate Diagnostics	Accelerate Diagnostics	Other	5 states

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