Horiba Medical Recalls ABX PENTRA Calcium CP Reagent for Incorrect Results
Horiba Medical is recalling ABX PENTRA Calcium CP Reagent because it may report incorrect calcium results on PENTRA 200 and 400 analyzers.
What this means for you
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: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The hazard is incorrect data reporting rather than direct physical injury.
Plain-English summary
Horiba Medical is recalling the ABX PENTRA Calcium CP Reagent, Model # A11A01633. The recall involves 2,658 units distributed worldwide, including the United States and Canada.
The recall was initiated because the reagent has the potential to report incorrect calcium results when used with PENTRA 200 and PENTRA 400 analyzers. The affected lot number is 014664503.
Customers of PENTRA 200 and PENTRA 400 systems should check their inventory for this specific reagent and lot number. If the product is present, it should be removed from use and returned to Horiba Medical in accordance with their instructions.
The recalled product
- Product
- ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and glycogen metabolism, extracellularly, in bone mineralization, in blood coagulation and in transmission of nerve impulses. Calcium
- Manufacturer
- Horiba Instruments, Inc dba Horiba Medical
- 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)
- Lot/Serial #(s): 014664503
Distribution
Distribution scope not specified by the agency.
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