CLASS II Device recall · Reported 26 Dec 2018 · FDA Enforcement Report
ultra2 Genesys Variants Analyzer recalled by Clark Laboratories, Inc. (
Clark Laboratories, Inc. ( is recalling ultra2 Genesys Variants Analyzer, distributed in Arizona, Illinois, Maryland, New Jersey, Utah, West Virginia. The recall was initiated on 1 Nov 2018 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-0620-2019
- FDA event ID
- 81488
- Recalling firm
- Clark Laboratories, Inc. (, Jamestown, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Nov 2018
- FDA classified
- 18 Dec 2018
- Reported
- 26 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 1 Nov 2018 | Recall initiated by company | |
| 18 Dec 2018 | Classified by FDA | +47 days |
| 26 Dec 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
lack of 510K
Product as listed by the FDA
ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
Where it was distributed
IL, WV, NJ, AZ, MD, UT
Questions about this recall
Is ultra2 Genesys Variants Analyzer recalled?
Yes. Clark Laboratories, Inc. ( recalled ultra2 Genesys Variants Analyzer on 1 Nov 2018. The recall is Class II and its status is Terminated. Recall number Z-0620-2019.
Why was it recalled?
lack of 510K
Which lots are affected?
all serial numbers
Where was it sold?
IL, WV, NJ, AZ, MD, UT
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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