FDA Device recall Z-0160-2016
BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103
- FDA Device
- Class II
- terminated
- Published 2015-11-04
On 2015-11-04 the FDA classified a Class II recall of BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103 by Lifehealth, citing 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 discr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0160-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-16 |
| Published | 2015-11-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Lifehealth |
| Distribution | US |
Product
BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103. BG Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint¿ Blood Analysis System.
Reason
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.
Identifiers
| code_info | EOSCU EOTUZ EOVMW EOYUL EPANW EPCED EPDVM EPFOJ EPIXX EPKOJ EPNXA |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0160-2016%22
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