Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat… — Class II medical device recall Z-2732-2017
Terminated recall by Nova Biomedical Corporation, reported 2017-07-19, distributed nationwide. Software- scheduled A-QC analysis could initiate prior to a patient result being released by the operator and
| Recall number | Z-2732-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nova Biomedical Corporation, Waltham, MA, United States |
| Recall initiated | 2017-06-19 |
| Classified | 2017-07-13 |
| Reported by FDA | 2017-07-19 |
| Terminated | 2018-08-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BD, BO, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DZ, EC, EG, FI, FR, GB, GH, GR, GT, GY, HK, HN, HU, IL, IN, IR, IS, IT, JO, JP, KE, KR, LK, LV, MX, MY, NG, NL, NP, PA, PE, PH, PK, PL, RU, SA, SI, SV, TH, TN, TR, TT, TW, UY, VN, ZA |
| Reason classes | software |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2732-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.