# FDA recall Z-2732-2017

> **Nova Biomedical Corporation** · Class II · device recall initiated 2017-06-19.

## Product

Nova Biomedical Stat Profile Prime Analyzer as follows:  PN 52855 Stat Profile Prime ABG Analyzer  PN 53655 Stat Profile Prime ABG Analyzer with Scanner  PN 52856 Stat Profile Prime CCS Analyzer  PN 53656 Stat Profile Prime CCS Analyzer with Scanner  PN 53657 Stat Profile Prime CCS Comp Analyzer with Scanner  PN 52857 Stat Profile Prime CCS Comp Analyzer  Blood Gas/Electrolyte/Metabolite/CO-Oximetry Analyzer

## Reason for recall

Software- scheduled A-QC analysis could initiate prior  to a patient result being released by the operator and result in the pending patient result being overwritten  with the A-QC test results.

## Distribution

Worldwide Distribution - US (Nationwide)  Foreign:  Albania  Algeria  Argentina  Australia  Austria  Bangladesh  Benin  Bolivia  Brazil  Canada  Chile  China  Colombia  Costa Rica  Czech Republic  ECUADOR  Egypt  El Salvador  Finland  France  Germany  Ghana  Greece  Guatemala  Guyana  Honduras  Hong Kong  Hungary  ICELAND  India  Iran  Israel  Italy  Ivory Coast  Japan  Jordan  Kenya  Korea  Latvia  Macedonia  Malaysia  Mexico  Nepal  Netherlands  Nigeria  Pakistan  Pakistan  Palestine  Peru  Philippines  Poland  Puerto Rico  Republic of Panama  Republica Dominicana  Russia  Saudi Arabia  Slovak Republic  Slovenia  South Africa  Sri Lanka  Switzerland  Taiwan  Thailand  The Netherlands  Trinidad,W.I.  Tunisia  Turkey  UK  Uruguay  Vietnam

## Key facts

- **Recall number:** Z-2732-2017
- **Recalling firm:** Nova Biomedical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-19
- **Report date:** 2017-07-19
- **Termination date:** 2018-08-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waltham, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2732-2017

## Citation

> AI Analytics. FDA recall Z-2732-2017. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-2732-2017. Source: US FDA. Licensed CC0.

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