Recalls / —
—#190646
Product
HARDY DIAGNOSTICS CatScreen, 25dsk/vial
- FDA product code
- JTO — Discs, Strips And Reagents, Microorganism Differentiation
- Device class
- Class 1
- Medical specialty
- Microbiology
- 510(k) numbers
- K960996
- Affected lot / code info
- Model Number HADZ110, all lots
Why it was recalled
Product stored incorrectly in temperature controlled setting instead of refrigeration.
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- MEDLINE INDUSTRIES, LP Northfield
- Address
- 3 Lakes Dr, Northfield, Illinois 60093-2753
Distribution
- Distribution pattern
- US Nationwide distribution in the state of California.
Timeline
- Recall initiated
- 2021-12-01
- Terminated
- 2023-01-09
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #190646. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.