Horiba Medical recalls ABX Pentra Micro Albumin 2 CP reagent due to potential overestimation of microalbumin levels in serum/plasma samples, which may affect test accuracy. Affected units include specific lot numbers and software versions.
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 of the microalbumin may be elevated more than 10%. This increase may affect serum, plasma and urine sample types.
Horiba Medical is recalling ABX Pentra Micro Albumin 2 CP reagents because using them with certain creatinine reagents can cause microalbumin test results to be too high by more than 10%. This error could lead to incorrect health assessments for kidney function.
The reagent can produce microalbumin levels that are 10% higher than expected when used immediately after a creatinine reagent. This error may cause false-positive kidney function readings in blood tests.
Healthcare providers using the ABX Pentra Micro Albumin 2 CP reagent with specific creatinine reagents for serum or plasma testing are most at risk of inaccurate kidney function results.
Check for the reagent code REF 1300032563. Affected units have software versions below V5.14 for Pentra 400 or below V1.07 for Pentra C400.
Verify your software version matches the affected versions listed in the recall notice.
The reagent can cause microalbumin test results to be elevated by more than 10% when used with specific creatinine reagents, potentially leading to inaccurate kidney function assessments.
Software versions below V5.14 for Pentra 400 and below V1.07 for Pentra C400.
No, but you should check your software version to ensure you are not using an affected version.
We’ve drafted a message you can send Horiba Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2286-2018 — Horiba Medical Horiba Medical Hello, I own a Horiba Medical that is covered by recall Z-2286-2018 from Horiba Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
