Accelerate Pheno system recall: Software Issue
Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product Usage: The Accelerate Pheno system is intended to…
Why was Accelerate Pheno system recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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
- 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…
- Recalling firm
- Accelerate Diagnostics Inc
- 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
- Recall date
- April 3, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)