CLASS II Device recall · Reported 9 Feb 2022 · FDA Enforcement Report
Hardy Diagnostics CatScreen, 25dsk/vial recalled
Medline Industries LP - Northfield is recalling Hardy Diagnostics CatScreen, 25dsk/vial, distributed nationwide in the US. The recall was initiated on 1 Dec 2021 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-0554-2022
- FDA event ID
- 89151
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Dec 2021
- FDA classified
- 2 Feb 2022
- Reported
- 9 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Test Kits & Diagnostics
Timeline
| 1 Dec 2021 | Recall initiated by company | |
| 2 Feb 2022 | Classified by FDA | +63 days |
| 9 Feb 2022 | 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
Product stored incorrectly in temperature controlled setting instead of refrigeration.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
HARDY DIAGNOSTICS CatScreen, 25dsk/vial
Where it was distributed
US Nationwide distribution in the state of California.
Questions about this recall
Why was it recalled?
Product stored incorrectly in temperature controlled setting instead of refrigeration.
Which lots are affected?
Model Number HADZ110, all lots
Where was it sold?
US Nationwide distribution in the state of California.
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 26 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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