Z-0207-2024 Class II Ongoing
FDA device recall Z-0207-2024 was initiated by Nova Biomedical Corporation on September 18, 2023 and is designated Class II. Reason for recall: Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the first 2-4 hours after c… The recall status is ongoing. Affected quantity: 1779 units: 438 US; 1341 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- November 8, 2023
- Initiation Date
- September 18, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1779 units: 438 US; 1341 OUS
Product Description
Reason for Recall
Distribution Pattern
Nationwide Foreign: Country Algeria Australia Austria Bangladesh Benin Bolivia Brazil Canada Chile China Colombia Croatia CYPRUS Czech Republic Ecuador Egypt El Salvador Finland France Germany Greece Guatemala India Indonesia Ireland Israel Italy Japan JORDAN Kazakhstan Kenya Kurdistan, Iraq Kuwait Malaysia Malta Mexico Moldova Morocco Nepal Netherlands New Zealand Oman Pakistan Palestine Paraguay Paraquay Peru Philippines Poland Puerto Rico Qatar Republic of Panama Romania Russia Rwanda Saudi Arabia Serbia Slovenia South Africa South Korea Spain Sri Lanka Sudan Sweden Switzerland Syria Thailand Trinidad Trinidad,W.I. Tunisia UK Ukraine United Arab Emerites Uruguay Vietnam