Device product
Lab Kit, SKU DYLAB1018; Component No. 503581
Z-0355-2025
Product summary
- Event
- Event 95628
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 626,305 Total Kits (US only)
- Official record key
device-enforcement:Z-0355-2025
Official wording
Reason: 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.
Code information: UDI-DI: 40195327088393 (Case); 10195327088392 (Ea) Lots: 24IMC246
Distribution pattern: US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.
Derived failure modes
-
Unknown
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.