FDA Medical Device Recalls (openFDA)
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 number
- Z-1717-2020
- Recalling firm
- Sysmex America, Inc.
- Product
- Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.
- Status
- Terminated
- Initiated
- 2020-01-21
- Posted
- not on file
- Terminated
- 2023-01-30
- Reason
- 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.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 40 units
- Distribution
- USA: FL, VT, IL.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KQO
- Firm FEI
- 1000515253
- Firm city
- Mundelein
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28