Laboratory tube sorters recalled over a lift that may drop unexpectedly
Sysmex America is recalling 44 TS-10/TS-10H Tube Sorters because the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement.
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: Scored 2 because the record cites unintended downward movement of a lift with no stated consequence or reported harm.
Plain-English summary
The TS-10/TS-10H Tube Sorter, an automatic sorting system for sorting barcoded sample tubes, catalog number BN168792, running software versions 00-17, is being recalled by Sysmex America, Inc.
The reason given in the enforcement record is that under specific conditions the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.
The record lists 44 units, with serial numbers recorded in the enforcement record. Distribution was nationwide in the United States. The FDA has classified the action as Class II.
The record names no further consequence and reports no injuries. Laboratories should follow Sysmex's instructions.
The recalled product
- Product
- TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17
- Manufacturer
- Sysmex America, Inc.
- Affected units
- 44
Distribution
Distributed nationwide across the United States.
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