Z-0554-2022Class II

HARDY DIAGNOSTICS CatScreen, 25dsk/vial

Name: Z-0554-2022 HARDY DIAGNOSTICS CatScreen, 25dsk/vial
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2021-12-01
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2021-12-01 / Terminated / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of HARDY DIAGNOSTICS CatScreen, 25dsk/vial on 2021-12-01. FDA classified it as Class II and gives the reason as "Product stored incorrectly in temperature controlled setting instead of refrigeration". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0554-2022
Classification: Class II
Status: Terminated
Initiated: 2021-12-01
Posted: 2022-02-02
Terminated: 2023-01-09
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: HARDY DIAGNOSTICS CatScreen, 25dsk/vial
Product code: JTO Discs, Strips And Reagents, Microorganism Differentiation
Reason for recall: Product stored incorrectly in temperature controlled setting instead of refrigeration.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medline notified consignees on 12/01/2021, via first class mail letter titled URGENT RECALL NOTIFICATION. Customers were instructed to immediately check stock for affected product, quarantine any affected product on hand, complete and return the response form indicating product destroyed, and notify customers if the product was further distributed.
Quantity in commerce: 100 units (4 packs, 25 per pack)
Distribution: US Nationwide distribution in the state of California.
Product codes and lots: Model Number HADZ110, all lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0554-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0554-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-09	2022-02-02

Product code JTO

K960996Class IM. Cat Butyrate DiskHardy Diagnostics / cleared 1996-04-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)