Abbott Diagnostics recalls HIV Combo : transit delays during thunderstorms may cause improper storage, risking incorrect or delayed HIV test results. Affected units include specific catalog and GTIN numbers.
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Abbott Diagnostics is recalling its HIV Combo 1x4ml Calibrator due to transit delays during severe thunderstorms. This could lead to improper storage conditions, increasing the risk of incorrect or delayed HIV test results.
The calibrator may have been stored outside recommended temperature conditions due to transit delays caused by severe thunderstorms. This could lead to incorrect or delayed HIV test results if the device is used without proper calibration.
Healthcare providers using the HIV Combo 1x4ml Calibrator for testing are likely affected. Those in regions with recent severe thunderstorms may be at higher risk due to potential storage issues.
Check for the catalog number 02P3601 or GTIN 380740003876 on the product label. The product was sold through Mckesson Medical-Surgical Inc. Corporate Office.
Ensure the calibrator has been stored within the recommended temperature range before use.
Transit delays during severe thunderstorms may have caused the calibrator to be stored outside recommended temperature conditions, increasing the risk of incorrect or delayed HIV test results.
The recall does not require immediate action; check storage conditions and ensure proper temperature before use.
No specific remedy is provided in the recall notice.
We’ve drafted a message you can send Abbott Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1845-2025 — Abbott Diagnostics Abbott Diagnostics Hello, I own a Abbott Diagnostics that is covered by recall Z-1845-2025 from Abbott Diagnostics. 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.
