LifeHealth Recalls IRMA TRUPOINT Blood Gas Analyzer CC Cartridges
LifeHealth, LLC is recalling IRMA TRUPOINT Blood Gas Analyzer CC Cartridges because the pH sensor may provide falsely elevated results as shelf life progresses.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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, but the source text does not report any specific injuries or illnesses.
Plain-English summary
LifeHealth, LLC is recalling 4659 boxes (116,475 cartridges) of IRMA TRUPOINT Blood Gas Analyzer CC Cartridges, product number 039903. These are single-use, disposable in vitro diagnostic devices intended for point-of-care, professional use with the IRMA TRUPOINT Blood Analysis System.
The recall was initiated because the pH sensor in the cartridges may report values outside of published performance specifications. Specifically, after a certain point in shelf life, the pH sensor may give results that are falsely elevated. The discrepancy increases as shelf life progresses and can be observed on aqueous controls before blood samples are tested.
The affected products were distributed nationwide in the United States and in numerous international locations, including Canada, the United Kingdom, and various countries in Europe, Asia, Africa, and the Americas. Users should stop using the affected cartridges and contact LifeHealth, LLC for further instructions.
The recalled product
- 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.
- Manufacturer
- LifeHealth, LLC
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)
- ASBEZ ASCXE ASEMB ASHWQ ASJMY ASLGI ASMXR ASOQO ASRXC ASTQR ASWZI
Distribution
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 →Related recalls
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