FDA Device recall Z-1065-2019
Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product Usage: The Accelerate Pheno system is inte…
- FDA Device
- Class II
- terminated
- Published 2019-04-03
On 2019-04-03 the FDA classified a Class II recall of Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product Usage: The Accelerate Pheno system is inte… by Accelerate Diagnostics, citing rare isolates of Enterobacteriaceae may generate a susceptible meropenem Minimum Inhibitory Concentration (MIC) using the affected device and a resistant result by broth microdilu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1065-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-13 |
| Published | 2019-04-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Accelerate Diagnostics |
| Distribution | US |
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.
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.
Identifiers
| code_info | REF: 10401008. Serial Numbers: 1324, 1325, 1431, 1432, 1084, 1087, 1367, 1362,1363,1615, 1616, 1358, 1359, 1453, 13…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1065-2019%22
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