Recalled Sekisui Diagnostics BVBLUE Bacterial Vaginosis test kits may have been stored at unsafe temperatures, risking inaccurate results. Consumers should check kit details and contact manufacturer for guidance.
Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes .
Sekisui Diagnostics' BVBLUE Bacterial Vaginosis test kits were recalled due to potential temperature issues in refrigerators. This could lead to inaccurate test results if the kits were exposed to temperatures outside the safe range for extended periods.
The kits were stored in walk-in refrigerators that experienced temperature drops below 35.6°F (2°C) for up to 60 minutes. This could cause the test results to be inaccurate if the kits were exposed to these conditions.
Healthcare facilities using these kits may have been affected by temperature excursions. Patients using the test kits at home are unlikely to be impacted since the kits are not designed for home use.
Check for the catalog number 184 and lot number CK233 on the kit packaging. These kits were sold by Mckesson Medical-Surgical Inc. in the U.S. starting from January 2024.
Look for catalog number 184 and lot number CK233 on the packaging to confirm if the kit is affected.
The kits were stored in walk-in refrigerators that experienced temperature drops below 35.6°F (2°C) for up to 60 minutes, potentially causing inaccurate test results.
No, the recall does not require discarding the kits. Consumers should check the kit details and contact the manufacturer for guidance.
No, these kits are designed for healthcare facilities, not home use, so home users are not at risk.
We’ve drafted a message you can send Sekisui Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1311-2024 — Sekisui Diagnostics Sekisui Diagnostics Hello, I own a Sekisui Diagnostics that is covered by recall Z-1311-2024 from Sekisui 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.
