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Terminated

HARDY DIAGNOSTICS CatScreen, 25dsk/vial

FDA Recall Z-0554-2022 · Posted None

Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusTerminated
Product CodeJTO
Date Initiated2021-12-01
Date Terminated2023-01-09
Product Quantity100 units (4 packs, 25 per pack)

Reason for Recall

Product stored incorrectly in temperature controlled setting instead of refrigeration.

Firm 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.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the state of California.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K960996M. CAT BUTYRATE DISKHardy Diagnostics · 1996-04-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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