Z-1065-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 3, 2019
- Initiation Date
- March 13, 2017
- Termination Date
- May 21, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 81
Product Description
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.
Distribution Pattern
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
Code Information
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