Aperio ScanScope Systems Recalled for Incorrect User Guide Labeling
Aperio Technologies is recalling 364 ScanScope systems because user guides incorrectly claim FDA clearance for diagnostic use, when the devices are for research only.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall involving a labeling error that could lead to misuse of a research device for diagnostic purposes, fitting the criteria for moderate severity due to potential risk of harm without reported injuries.
Plain-English summary
Aperio Technologies Inc. is recalling 364 units of the Aperio ScanScope System, including models XT, AT, AT Turbo, CS, and CSO. These automated digital slide creation and viewing devices are intended to create and view electronic image files of tissue specimens fixed to glass slides.
The recall was initiated because the User Guides incorrectly state that the devices have been cleared for specific applications. The guides should state that the devices are for Research Use Only and are not for use in diagnostic procedures.
The affected units were distributed nationwide, including all states, but not internationally. Users should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected.
The recalled product
- 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 create and view electronic image files representative of tissue specimens fixed to glass slides.
- Manufacturer
- Aperio Technologies Inc
- Hazard
- Affected units
- 364
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- esa 1223
- 1273
- 1278
- 1277
- 1282
- 1593
- 1605
- 1648
- 1657
- 1660
- 5064
- 5068
- 5108
- 5155
- 5170
- 5171 1285
- 1286
- 1287
- 1293
- 1296
Distribution
Distributed nationwide across the United States.
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