Accelerate Pheno system — Class II medical device recall Z-1065-2019
Terminated recall by Accelerate Diagnostics Inc, reported 2019-04-03, distributed nationwide. Rare isolates of Enterobacteriaceae may generate a susceptible meropenem Minimum Inhibitory Concentration (MIC
| Recall number | Z-1065-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accelerate Diagnostics Inc, Tucson, AZ, United States |
| Recall initiated | 2017-03-13 |
| Classified | 2019-03-27 |
| Reported by FDA | 2019-04-03 |
| Terminated | 2021-05-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, ES, GB, IT |
| Quantity | 81 |
| Reason classes | software |
| Serial numbers | 1084, 1087, 1135, 1144, 1145, 1148, 1149, 1150, 1151, 1176, 1178, 1231, 1238, 1247, 1249, 1254, 1260, 1264, 1265, 1277, 1278, 1282, 1284, 1286, 1288 and 55 more |
| Model numbers | 10401008 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1065-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.