Z-0360-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2024
- Initiation Date
- October 23, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 626,305 Total Kits (US only)
Product Description
URINE KIT, SKU DYKM1845; Component No. 503581
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.
Distribution Pattern
US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.
Code Information
UDI/DI: 40193489713993 (Case), 10193489713992 (Ea), Lots 10193489713992 21GMF840 21KMA595 22AMG015 22BMH241 22CMG029 22DMI870 22FMA088 22HMH213 22JMH449 22LMH860 23CMA518 23CMG948 23DMG087 23EMH568 23GMD322 23HME585 23IMG193 23KMD763 24AMD430 24CMA930 24CMD335 24DMA485 24FMF320 24GMJ197 24IME270