FDA Device recall Z-1919-2015
LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings
- FDA Device
- Class II
- terminated
- Published 2015-07-08
On 2015-07-08 the FDA classified a Class II recall of LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings by Lifehealth, citing the barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will drift over time.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1919-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-29 |
| Published | 2015-07-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Lifehealth |
| Distribution | MI |
Product
LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro measurement of various critical care analytes in human whole blood. These analytes includes: pO2, pCO2, pH, iCa, Na, K and Cl.
Reason
The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will drift over time.
Identifiers
| code_info | 44803, 44805, 44807, 44808, 44818, 44830, 44837 |
|---|
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-1919-2015%22
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