Sysmex recalls CV-11 Sample Units with serial numbers 11201-15620 due to urine spills causing potential smoke/sparks and fire risk. Affected units may need replacement.
When excessive amounts of urine spills on the rack transport track and reaches the electrical components of the CV-11 conveyor, there is a potential for smoke and/or sparks which may present a combustion hazard.
Sysmex is recalling CV-11 Sample Units that could catch fire if urine spills on the internal electrical components. This is a serious hazard that requires immediate action to prevent fire.
Urine spills on the rack transport track can reach electrical components, causing smoke or sparks. This creates a fire hazard if the unit is left unattended during urine sample processing.
Lab technicians and medical facilities using Sysmex CV-11 Sample Units with serial numbers listed in the recall. Those handling urine samples are most at risk.
Check the serial number on your CV-11 Sample Unit. Affected units have serial numbers from 11201 to 15620 as listed in the recall notice.
Immediately stop using the CV-11 Sample Unit if it has a serial number from 11201 to 15620.
Urine spills on the rack transport track can reach electrical components, causing potential smoke or sparks that may lead to fire.
Serial numbers 11201, 11202, 12310, 12311, 12312, 12313, 12941, 12942, 12997, 13875, 14170, 14171, 14172, 14173, 14174, 14175, 14278, 14279, 14280, 14962, 14963, 14964, 14965, 14966, 14967, 14968, 14969, 14970, 14972, 14973, 14974, 14975, 14976, 14977, 14978, 14979, 15017, 15018, 15619, 15620.
The recall notice does not specify a replacement process or alternative units.
We’ve drafted a message you can send Sysmex to request your refund or repair — edit it as you like.
Subject: Recall Z-1717-2020 — Sysmex Sysmex Hello, I own a Sysmex that is covered by recall Z-1717-2020 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.