Lower risk Medical device recall · FDA · Published December 1, 2021

Hardy Diagnostics CatScreen 25-disk/vial recall: Temperature storage error

Hardy Diagnostics CatScreen 25-disk/vial (Model HADZ110) recalled due to improper storage in temperature-controlled settings instead of refrigeration. No remedy specified.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0554-2022Medical device Hardy Diagnostics ›

Lower-risk recall

Product stored incorrectly in temperature controlled setting instead of refrigeration.

Take action

Contact the company

Recalling firmMEDLINE INDUSTRIES, LP - Northfield3 Lakes Dr · Northfield, IL 60093-2753

✎ GovInfoNow plain-language explainer

Hardy Diagnostics CatScreen 25-disk/vial products (Model HADZ11:10) are recalled because they were stored incorrectly in temperature-controlled settings instead of refrigeration. This could lead to product damage or inaccurate results if used improperly. Read more at govinfonow.com/recall/61483-hardy-diagnostics-catscreen-25-disk-vial-recall-temperature-storage-error.

Source Summary by GovInfoNow · govinfonow.com/recall/61483-hardy-diagnostics-catscreen-25-disk-vial-recall-temperature-storage-error · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0554-2022

Cite this page

“Hardy Diagnostics CatScreen 25-disk/vial recall: Temperature storage error.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61483-hardy-diagnostics-catscreen-25-disk-vial-recall-temperature-storage-error. Based on FDA recall #Z-0554-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0554-2022%22&limit=1).

The FDA announced on 2021-12-01 that Hardy Diagnostics, a brand of MEDLINE INDUSTRIES, LP - Northfield, recalled CatScreen products due to improper storage. The hazard stems from the product being stored in a temperature-controlled setting instead of refrigeration.

How to tell if you have it

Brand: Hardy Diagnostics
Product: HARDY DIAGNOSTICS CatScreen, 25dsk/vial
Model Number: HADZ110
Lots: all lots

The hazard

The recalled product was stored incorrectly in a temperature controlled setting instead of refrigeration.

Context

GovInfoNow's records show MEDLINE INDUSTRIES, LP - Northfield has had 119 other recalls on record since 2021-10-22. Recent Medline recalls include medical kits with light failure in intubation trays (2025-07-25), Foley Tray Kits with incorrect labeling risk (2025-07-23), and Reprocessed St. Jude Catheters that may contain particulates (2025-07-14). Other recent recalls of similar products include Medline Convenience Kits Recall: Temperature Probes May Have Distribution Error (2026-05-28) and BD Pyxis MedStation ES Tower 352 Medication Cabinet Recall: Fingerprint Scanner Overheats Risk (2026-04-30).

How to tell if you have this one

Check for the Hardy Diagnostics CatScreen 25-disk/vial product with Model Number HADZ110. All lots are affected as the recall covers all units.

Brand
Hardy Diagnostics
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Storage Conditions
Ensure the product is stored in a refrigerator, not a temperature-controlled setting.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution in the state of California.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 13 months after the firm started it.

Dec 1, 2021Firm started the recall
Feb 2, 2022FDA classified it Class II
Feb 9, 2022Published in FDA’s Enforcement Report
Jan 9, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

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Keep exploring

More Hardy Diagnostics recalls

Link to this recall

<a href="https://govinfonow.com/recall/61483-hardy-diagnostics-catscreen-25-disk-vial-recall-temperature-storage-error">Hardy Diagnostics CatScreen 25-disk/vial recall: Temperature storage error (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0554-2022 (December 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0554-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.