Horiba Medical Recalls ABX PENTRA Magnesium RTU Reagent for Stability Update
Horiba Medical is recalling ABX PENTRA Magnesium RTU Reagent to update on-board stability claims from 7 days to 1 day.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary precautionary recall involving a labeling and stability claim update without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Horiba Medical is recalling the ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646. The product is used for the quantitative in vitro diagnostic determination of magnesium in human serum and plasma. The recall involves 359 units distributed nationwide in the United States.
The recall is being conducted because the on-board stability claims for the reagent have been updated. Horiba Medical has revised the package inserts to remove the previous 7-day on-board stability claim and replace it with a 1-day on-board stability claim. This change ensures that users are aware of the correct timeframe for the reagent's stability once it is loaded into the instrument.
Healthcare facilities and laboratories that have received this product should stop using the reagent and follow the instructions provided by Horiba Medical for the return or disposal of the affected units. This recall is a precautionary measure to ensure accurate diagnostic results and proper handling of the reagent.
The recalled product
- Product
- ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using…
- Manufacturer
- Horiba Instruments, Inc dba Horiba Medical
- Hazard
- Affected units
- 359
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)
- All Lots
Distribution
Distributed nationwide across the United States.
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