Horiba Medical Recalls ABX Pentra Micro Albumin Reagents Due to Result Elevation
Horiba Medical is recalling ABX Pentra Micro Albumin 2 CP reagents because they may produce elevated results if used immediately after a specific creatinine reagent.
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 II. The hazard involves potential test result inaccuracy (elevation >10%) without reported injuries or illnesses, fitting the criteria for a moderate severity recall involving low-risk contamination or labeling/functional errors.
Plain-English summary
Horiba Instruments, Inc dba Horiba Medical is recalling 686 units of ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563. The recall covers devices distributed in the United States and internationally to Bulgaria, Burma, Cameroon, Djibouti, France, Gabon, Germany, Italy, Lebanon, Mali, Mauritania, Poland, Portugal, Romania, Saudi Arabia, South Africa, and Thailand.
The recall is due to a potential inaccuracy in test results. When the ABX Pentra Micro ALBUMIN 2 CP (ALBT2) Reagent 2 is sampled and dispensed immediately after an ABX Pentra Creatinine 120 CP (CREA3) Reagent 2 dispense, the final result for microalbumin may be elevated by more than 10%. This issue may affect serum, plasma, and urine sample types.
The affected software versions are Application versions V5.14 and V2.12 for Pentra 400, and Version V1.07 for Pentra C400. The source text does not specify specific actions for consumers or healthcare providers, such as whether to stop using the device or contact the manufacturer.
The recalled product
- Product
- ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a variety of analytes.
- 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)
- All lot numbers
Distribution
Distributed nationwide across the United States.
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