Sysmex America, Inc. Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.
Brand
Sysmex America, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Sysmex America, Inc. is recalling Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The firm initiated the recall by letter on January 21, 2020. The "Product Notification", identified the Field Correction and instructed the customer to use the kit to direct fluid safety away from the conveyor electrical parts to address this potential hazard. During the next service visit, this kit will be installed by your Sysmex Field Service Engineer. The Notification also instructs the customer to: 1. Ensure that the surface of the sample, in the two, is more than away from the opening of the two. 2. Do not store samples on or above the analyzer. 3. if the sample transport conveyor unexpectedly stop, freezes, or jams, immediately remove all samples racks from the conveyor, before reinitializing or resetting analyzer or conveyor. 4. In the event of a sample spill on the conveyor, turn off the power to the equipment immediately and clean up any visible spills. If a spill occurs prior to the installation of the spill countermeasure kit, contact the Sysmex Technical Assistance Center (TAC). A Sysmex representative can explain how to properly clean the spill or will dispatch a Field Service Engineer. 5. Please distribute this Product Notification as appropriate to your laboratory staff. 6. File this Product Notification as a part of your laboratory's Quality System as required. the notice provided the contact information of the Technical Assistance Center at 1 888 879 7639 in the U.S., or at 1 888 679 7639 in Canada.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, IL, VT
Page updated: Jan 10, 2026