BD Bio Sciences recalls BD Trucount Controls 30-Test kits with incorrect standard deviation values, risking inaccurate bead counts in lab testing. Affected kits distributed outside the US.
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
BD Bio Sciences is recalling BD Truc:ount Controls 30-Test kits because they contain incorrect standard deviation values for control beads. This can lead to inaccurate bead count calculations in laboratory testing, potentially affecting test results.
The control kits contain incorrect standard deviation (SD) values for low and high control beads. This error can cause inaccurate bead count calculations, which may lead to unreliable test results in laboratory settings.
Laboratory users who purchased BD Trucount Controls 30-Test kits with the specified lot number (85708) or unique identifier (00382903403356) are affected. Researchers and lab technicians using these kits for testing are most at risk.
Check for the lot number 85708 and unique identifier 00382903403356 on the kit packaging. These kits were distributed outside the US and are part of the recall.
Verify the lot number (85708) and unique identifier (00382903403356) on the BD Trucount Controls 30-Test kit packaging.
The control kits contain incorrect standard deviation values for low and high control beads, which can compromise accurate bead count calculations in laboratory testing.
Check for the lot number 85708 and unique identifier 00382903403356 on the kit packaging. These kits were distributed outside the US.
The recall record does not specify a remedy, so no action is required beyond checking the kit details.
We’ve drafted a message you can send BD Bio Sciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2238-2025 — BD Bio Sciences BD Bio Sciences Hello, I own a BD Bio Sciences that is covered by recall Z-2238-2025 from BD Bio Sciences. 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.
