FDAFDA · Food and drugs·Recall number Z-1549-2013
Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated digital slide creation and viewing device. It is intended to create and view electronic image files representative of tissue specimens fixed to glass slides.
Published June 26, 2013 · Recall initiated: February 22, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Aperio initiated this recall because the User Guides incorrectly state the devices had been cleared for specific applications. The User Guides should state the devices are for Research Use Only and are not for use in diagnostic procedures.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aperio Technologies Inc
- Distributor
- Nationwide Distribution - including all states, none internationally .
- Lot
- The following serial numbers of the Aperio ScanScope systems are affected in the USA by this recall: ¿ScanScope XT ScanScope AT ScanScope ATT ScanScope es, esa 1223, 1273, 1278, 1277, 1282, 1593,1605, 1648,1657,1660, 5064,5068,5108,5155,5170,5171 1285,1286,1287,1293,1296, 1619, 1620, 1662,1663,1666, 5176,5181,5187,5196,5198,5202, 1299,1300,1301,1302,1304, 1623, 1633, 1671, 1672, 1673, 5204,5205,5233,5236,5237,5241, 1311,1312,1314,1315,1316, 1634,1635, 1676, 1678, 1679, 5244,5245,5246,5248,5253,5262, 1318,1319,1320,1321,1322, 1636, 1637, 1690, 1692, 1695, 5266,5267,5269,5270,5272,5276, 1324,1325,1327,1328,1330, 1638,1640, 1698,1700,1718 5277,5279,5283,5287,5288,5293, 1332, 1333, 1335, 1336, 1338, 1643,1645, 5294, 5295, 5302, 5307, 5308, 5309, 1339, 1340, 1342, 1343, 1345, 1649,1654, 5314,5315,5316,5317,5324,5327, 1350,1352,1357,1358,1359, 1656,1664, 5328,5329,5330,5331,5333,5334, 1366, 1368, 1369, 1370, 1372, 1686, 1687, 5336,5339,5340,5341,5345,5347, 1382,1383,1392,1394,1396, 1688, 1689, 5348,5352,5353,5356,5367,5371, 1397, 1399, 1400, 1402, 1404, 1696, 1699, 5374,5379,5381,5388,5390,5394, 1405,1407,1409,1410,1413, 1703,1705, 5396,5402,5403,5404,5405,5406, 1417,1418,1419,1420,1421, 1707, 1708, 5408,5409,5415,5416,5418,5419, 1422, 1423, 1424, 1425, 1426, 1709,1711, 5433,5440,5452,5456,5457,5459, 1436,1441,1442,1444,1445, 1714,1716, 5462,5465,5466,5467,5468,5469, 1446, 1448, 1449, 1450, 1452, 1719,1721, 5470,5473,5475,5476,5477,5478, 1453, 1454, 1456, 1457, 1458, 1723,1724, 5482,5485,5486,5489,5490,5492, 1460,1461,1466,1475,1476, 1725,1727, 5493,5504,5515,5516,5517,5518, 1481,1482,1486,1487,1490, 1728,1729, 5520, 5529, 5537, 5540, 5552, 5566, 1492, 1499, 1500, 1502, 1503, 1731,1733, 5567,5574,5578,5581,5587,5590, 1505,1506,1507,1508,1509, 1735, 1736, 5591,5592,5593 1511,1512,1514,1515,1516, 1739,1744 1517,1519,1520,1522,1523, 1525, 1527, 1528, 1532, 1534, 1535, 1536, 1537, 1538, 1540, 1542,1543,1544,1545,1546, 1547,1548,1549,1550,1551, 1552, 1553, 1554, 1556, 1557, 1559,1560,1563,1564,1569, 1570, 1571, 1575, 1576, 1582, 1586,1587,1588,1590,1591, 1596,1597,1611,1627
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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