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Terminated

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.

FDA Recall Z-2687-2020 · Posted None

Recalling FirmSysmex America, Inc.
Recall StatusTerminated
Product CodePER
Date Initiated2020-07-06
Date Terminated2021-05-21
Product Quantity8 units

Reason for Recall

Insufficient amount of antibody without an error message or alarm

Firm Action

Sysmex issued a field corrective action on July 6, 2020. The product notification states the following actions to be taken: 1. A Sysmex Service Engineer will be scheduled to adjust the probe height to correct the issue from occurring when using the Sysmex antibody vials. The PS-10 should not be used to perform any testing, other than internal validation, until the adjustment is completed. 2. Discontinue use of non-Sysmex antibody vials in the PS-10 for testing until Sysmex hascompleted the verification, unless your internal procedures ensure the required accuracy of the pipetted volume. 3. Please distribute this Product Notification as appropriate to your laboratory 4. File this Product Notification as a part of your laboratorys Quality System as required For urgent requests, call the Technical Assistance Center at 1-888-879- 7639 in the U.S., or at 1-888-679-7639 in Canada

Root Cause

Software design

Distribution Pattern

US Nationwide distribution including in the states of AL, AZ, MD, WA, FL, IL.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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