CLASS II Device recall · Reported 22 Apr 2020 · FDA Enforcement Report
Sysmex CV-11 Sample Unit, an integrated modular sampler recalled
Sysmex America is recalling Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either, distributed in Florida, Illinois, Vermont. The recall was initiated on 21 Jan 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1717-2020
- FDA event ID
- 84759
- Recalling firm
- Sysmex America, Mundelein, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jan 2020
- FDA classified
- 15 Apr 2020
- Reported
- 22 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 21 Jan 2020 | Recall initiated by company | |
| 15 Apr 2020 | Classified by FDA | +85 days |
| 22 Apr 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.
Where it was distributed
USA: FL, VT, IL.
Questions about this recall
Is Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either recalled?
Yes. Sysmex America recalled Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either on 21 Jan 2020. The recall is Class II and its status is Terminated. Recall number Z-1717-2020.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
USA: FL, VT, IL.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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