Sysmex PS-10 Sample Preparation System Recalled for Insufficient Antibody
Sysmex America, Inc. is recalling eight PS-10 Sample Preparation Systems because they may contain insufficient antibody without triggering an error message or alarm.
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 3/5 (High).
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: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Sysmex America, Inc. is recalling eight units of the Sysmex PS-10 Sample Preparation System (Catalog number BQ716341). The device is a fully automated, user-configurable, open system intended to prepare human specimens for subsequent analysis on flow cytometers.
The recall is being issued because the systems may contain an insufficient amount of antibody without providing an error message or alarm to the user. This defect could potentially affect the accuracy of specimen preparation.
The affected units were distributed nationwide in the United States, including in the states of Alabama, Arizona, Maryland, Washington, Florida, and Illinois. The specific serial numbers for the recalled units are 1906007896, 1907014703, 1908002274, 1908002273, 1907014704, 1903011967, 1903011968, and 1903011966. Users should check their serial numbers and contact Sysmex America, Inc. for further instructions.
The recalled product
- Product
- Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable, open system intended for use to prepare human specimens for subsequent analysis on flow cytometers.
- Manufacturer
- Sysmex America, Inc.
- Affected units
- 8
Distribution
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