Nova Biomedical Corporation: Medical Device Recall in 2023 - (Recall #: Z-0207-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 57400 Stat Profile Prime Plus Analyzer (2) PN 59508 Stat Profile Prime Plus Analyzer, Remanufactured

Product Classification:

Class II

Date Initiated: September 18, 2023

Date Posted: November 8, 2023

Recall Number: Z-0207-2024

Event ID: 93095

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 cartridge installation that may not be identified by traditional Quality Control practices.

Status: Ongoing

Product Quantity: 1779 units: 438 US; 1341 OUS

Code Information:

UDI-DI: (1) 00385480574006 (2) 00385480595087 All software versions (V1.17.1123.0 and V3.2.1123.0)

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

Voluntary or Mandated:

Voluntary: Firm initiated