Becton Dickinson recalls BD MAX DNA MMK Lab Use (catalog 442828) from August 2014 due to incorrect primer/probe diluent volume in package inserts, potentially affecting assay results.
The package insert incorrectly lists the volume of the primer and probe diluent to use for the reconstitution of the master mix tube. Adding the incorrect amount of diluent could have an effect on the assay.
Becton Dickinson is recalling BD MAX DNA MMK Lab Use products (catalog number 442828) made since August 2014 because the package inserts list the wrong volume of diluent for reconstitution. This could lead to inaccurate assay results if users follow the incorrect instructions.
The package insert incorrectly states the volume of diluent needed to mix with the master mix. If users add the wrong amount of diluent, the assay results could be inaccurate. This is a technical error in the instructions, not a physical hazard.
Lab users who purchased BD MAX DNA MMK Lab Use (catalog 442828) since August 2014 are affected. Researchers and lab technicians using these products for DNA analysis are most at risk of inaccurate results.
Check for the product name 'BD MAX DNA MMK Lab Use' with catalog number 442828. The products were sold starting August 20, 2014.
Check the package insert for the correct diluent volume before use to ensure accurate assay results.
No, this is a technical error in the package instructions that could lead to inaccurate assay results, not a physical hazard.
Review the package instructions for the correct diluent volume to ensure accurate results. There is no need to stop using the product.
The recall applies to BD MAX DNA MMK Lab Use (catalog 442828) sold starting August 20, 2014.
We’ve drafted a message you can send Becton Dickinson to request your refund or repair — edit it as you like.
Subject: Recall Z-1545-2018 — Becton Dickinson Becton Dickinson Hello, I own a Becton Dickinson that is covered by recall Z-1545-2018 from Becton Dickinson. 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.
