Mckesson recalls ABX Pentra Creatinine reagents produced between May 2021 and September 2021 due to potential temperature excursions affecting product effectiveness. Consumers should check lot numbers and contact the manufacturer for details.
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.
Mckesson is recalling ABX Pentra Creatinine reagents that were produced between May and September 2021. These reagents may have been affected by temperature changes during shipping, which could reduce their effectiveness. This recall does not pose an immediate safety risk but could impact test accuracy.
The reagents were exposed to temperature fluctuations between June 2021 and August 2021 during shipping. This could have reduced their effectiveness, leading to inaccurate creatinine test results. The hazard is not a physical danger but a potential impact on test accuracy.
Healthcare facilities that used these reagents between May 30, 2021 and September 8, 2021. Laboratory staff and patients using these reagents for creatinine testing are most at risk of inaccurate results.
Check for lot numbers between 5/30/2021 and 9/8/2021. The product includes model numbers 1220001933 and GTIN 03610230005736. The reagents were distributed by Mckesson Medical-Surgical.
Look for lot numbers distributed between May 30, 2021 and September 8, 2021 on the reagent packaging.
The reagents were exposed to temperature fluctuations between June 2021 and August 2021 during shipping, which may have reduced their effectiveness.
Check for lot numbers distributed between May 30, 2021 and September 8, 2021. The product model numbers are 1220001933 and GTIN 03610230005736.
The recall does not require immediate action, but you should check with Mckesson Medical-Surgical to confirm if your reagents need replacement.
We’ve drafted a message you can send Mckesson Medical-Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1586-2022 — Mckesson Medical-Surgical Mckesson Medical-Surgical Hello, I own a Mckesson Medical-Surgical that is covered by recall Z-1586-2022 from Mckesson Medical-Surgical. 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.