Sysmex PS-10 Sample Preparation System Recalled for False Test Results
Sysmex PS-10 Sample Preparation Systems may produce false test results due to sporadic omission of the probe wash step during antibody pipetting. Thirty-two units have been recalled nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device that can produce false laboratory test results due to a functional defect. Although no illnesses or injuries have been reported, false test results in clinical settings represent a significant risk of patient harm through misdiagnosis, meeting the criteria for High severity.
Plain-English summary
The FDA is recalling Sysmex PS-10 Sample Preparation Systems with software versions 1.5 and 1.6 (Catalog Number BQ716341) manufactured by Sysmex America, Inc. The recall affects 32 units distributed nationwide in the United States.
The systems can produce false test results due to carryover contamination. This occurs when the probe wash step is sporadically omitted during antibody pipetting, allowing materials from one sample to contaminate the next and generate inaccurate test results.
Any laboratory or medical facility using an affected system should verify their equipment against the serial number list provided in the FDA recall notice. Facilities with matching serial numbers should follow guidance from Sysmex America, Inc. regarding remedial actions.
The recalled product
- Product
- Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for automated pipetting, diluting, and specimen processing workstations for flow cytometric analysis.
- Manufacturer
- Sysmex America, Inc.
- Hazard
- false-results
- carryover-contamination
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 (1)
- UDI-DI: 04987562501908
Distribution
Distributed nationwide across the United States.
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