The Recall Desk
HighFDA (Devices)·Z-0160-2016·Announced 2015-11-04

LifeHealth Recalls BG Cartridges for IRMA TRUPOINT Blood Gas Analyzer

LifeHealth is recalling BG cartridges for the IRMA TRUPOINT Blood Gas Analyzer because the pH sensor may provide falsely elevated results as the product ages.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves inaccurate diagnostic results (falsely elevated pH) which poses a risk of harm to patients through potential misdiagnosis or treatment, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

LifeHealth, LLC is recalling BG cartridges for the IRMA TRUPOINT Blood Gas Analyzer, product number 048103. These are single-use, disposable in vitro diagnostics intended for point-of-care, professional use with the IRMA TRUpoint Blood Analysis System. The recall involves 1,735 boxes of 25 cartridges, totaling 43,375 units.

The recall is being issued because the cartridges may report values outside the published performance specifications for pH. Specifically, after a certain point in their shelf life, the pH sensor may give results that are falsely elevated. The discrepancy increases as the shelf life progresses and can be observed on aqueous controls before it is seen in blood samples.

The affected products were distributed nationwide in the United States and in numerous countries internationally, including Canada, the United Kingdom, Germany, and Japan. Users of these cartridges should stop using them and contact LifeHealth, LLC for further instructions or a replacement.

The recalled product

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.
Manufacturer
LifeHealth, LLC
Category
Medical Device — In Vitro Diagnostics
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • EOSCU EOTUZ EOVMW EOYUL EPANW EPCED EPDVM EPFOJ EPIXX EPKOJ EPNXA

Distribution

Distributed nationwide across the United States.

The notice also names 26 states specifically:

Part of a larger recall action

This product is one of 2 recalled by LifeHealth, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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