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Open, Classified

URINE KIT, SKU DYKM1845; Component No. 503581

FDA Recall Z-0360-2025 · Posted 2024-11-12

Recall StatusOpen, Classified
Product CodeLRO
Date Initiated2024-10-23
Product Quantity626,305 Total Kits (US only)

Reason for Recall

Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.

Firm Action

On October 23, 2024, the firm notified customers via Medical Device Recall letters sent through First Class Mail and Email. Customers were informed that the product is actually non-sterile and provided with the full list of impacted convenience kits. Once customers submit the recall response form, they will receive an over-label to place on affected kits, which instruct the user to remove the recalled component. Customers who would like a replacement specimen container may contact their sales representative. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.

Official Source

View FDA Recall →

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

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