Aperio ScanScope System. Aperio ScanScope recall
Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated digital slide creation and viewing device. It is intended to…
Why was Aperio ScanScope System. Aperio ScanScope recalled?
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 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?
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
- Product
- Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated digital slide creation and viewing device. It is intended to…
- Recalling firm
- Aperio Technologies Inc
- Quantity
- 364
- Distribution
- Nationwide Distribution - including all states, none internationally .
- Recall date
- June 26, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)