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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 33728

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 22, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Aperio Technologies Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1549-2013
Recall number
Z-1549-2013
Initiated
February 22, 2013
Classification
Class II
Status
Terminated
Recalling firm
Aperio Technologies Inc
Quantity
364

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Nationwide Distribution - including all states, none internationally .