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U.S. Department of Health and Human Services

Class 2 Device Recall Sysmex CV11 Sampler

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 Class 2 Device Recall Sysmex CV11 Samplersee related information
Date Initiated by FirmJanuary 21, 2020
Create DateApril 15, 2020
Recall Status1 Terminated 3 on January 30, 2023
Recall NumberZ-1717-2020
Recall Event ID 84759
Product Classification Automated urinalysis system - Product Code KQO
ProductSysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.
Code Information 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
FEI Number 1000515253
Recalling Firm/
Manufacturer		 Sysmex America, Inc.
1 Sysmex Way
Mundelein IL 60060-9528
For Additional Information ContactNancy Gould
224-543-9678
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Process control
ActionThe 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 in Commerce40 units
DistributionUSA: FL, VT, IL.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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