Sysmex recalls PS-10 Sample Preparation System with catalog number BQ716341 due to insufficient antibody causing errors without alarms. Affected units have specific serial numbers listed.
Insufficient amount of antibody without an error message or alarm
Sysmex is recalling its PS-10 Sample Preparation System because it may not have enough antibody, which can lead to errors in testing without warning. This could affect lab results if the device is used without proper alerts.
The device may not have enough antibody, which can cause errors in sample preparation without alerting the user. This could lead to inaccurate lab results if the system is used without proper error messages.
Lab technicians and medical facilities using the Sysmex PS-10 system with the listed serial numbers are most at risk. The recall affects specific units sold with catalog number BQ716341.
Check for the catalog number BQ716341 on the device. Affected units have specific serial numbers listed in the recall notice: 1906007896, 1907014703, 1908002274, 1908002273, 1907014704, 1903011967, 1903011968, 1903011966.
Compare your device's serial number with the list provided: 1906007896, 1907014703, 1908002274, 1908002273, 1907014704, 1903011967, 1903011968, 1903011966.
The Sysmex PS-10 Sample Preparation System may not have enough antibody, which can cause errors in testing without alerting the user.
Check your device's serial number against the list provided: 1906007896, 1907014703, 1908002274, 1908002273, 1907014704, 1903011967, 1903011968, 1903011966.
The recall does not mention a fix or remedy; affected units should be checked against the serial numbers listed.
We’ve drafted a message you can send Sysmex to request your refund or repair — edit it as you like.
Subject: Recall Z-2687-2020 — Sysmex Sysmex Hello, I own a Sysmex that is covered by recall Z-2687-2020 from Sysmex. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
