HORIBA ABX Pentra Etching CP Solution (ABX Pentra 400 Clinical) recalled due to temperature excursions from June 2021-August 2021 potentially impacting product effectiveness. All lots distributed between May 30, 2021 and June 9, 2021 are affected.
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
HORIBA ABX Pentra Etching CP Solution for ABX Pentra 400 Clinical Chemistry Analyzers was recalled because temperature issues during shipping from June 2021 to August 2021 could have reduced product effectiveness. This affects specific lots distributed between May 30 and June 9, 2021.
The solution may have been exposed to temperatures outside the recommended range during shipping from June 2021 to August 2021, which could reduce its effectiveness for clinical testing. This issue occurred before the product reached the end user.
Healthcare facilities using the ABX Pentra 400 Clinical Chemistry Analyzer with the affected solution lots (distributed May 30-June 9, 2021) are most at risk. The recall targets specific product lots that may have been impacted by temperature variations during shipping.
Check the product label for the lot number, which should be between 5/30/2021 and 6/9/2021. The product is a 25 mL solution for ABX Pentra 400 Clinical Chemistry Analyzers.
Look for the lot number on the product label, which should be between May 30, 2021 and June 9, 2021.
The product was recalled because temperature excursions during shipping from June 2021 to August 2021 may have impacted its effectiveness.
The ABX Pentra Etching CP Solution (25 mL) for ABX Pentra 400 Clinical Chemistry Analyzers with lot numbers distributed between May 30, 2021 and June 9, 2021.
The recall record does not mention any remedy or fix for this issue.
We’ve drafted a message you can send HORIBA ABX Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1585-2022 — HORIBA ABX Medical HORIBA ABX Medical Hello, I own a HORIBA ABX Medical that is covered by recall Z-1585-2022 from HORIBA ABX 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.
