CC cartridges for IRMA TRUPOINT Blood Gas Analyzer — Class II medical device recall Z-0159-2016
Terminated recall by LifeHealth, LLC, reported 2015-11-04, distributed nationwide. May report values outside the published performance specifications for pH. After a certain point in shelf life
| Recall number | Z-0159-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LifeHealth, LLC, Roseville, MN, United States |
| Recall initiated | 2015-09-16 |
| Classified | 2015-10-23 |
| Reported by FDA | 2015-11-04 |
| Terminated | 2016-03-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BE, BO, CA, CL, CN, DE, DK, DO, EC, EE, EG, ES, FR, GB, GR, ID, IE, IS, IT, JM, JP, KR, MA, NL, NO, PE, PH, PT, TN, TR, TW, VN, ZA |
Product
CC cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 039903. The CC Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint¿ Blood Analysis System.
Reason for recall
May report values outside the published performance specifications for pH. After a certain point in shelf life, the pH sensor may give results that are falsely elevated. The discrepancy is greater as shelf life progresses and can be seen on the aqueous controls before the blood.
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-0159-2016. 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.