Becton Dickinson recalls BD MAX DNA MMK (SPC) lab reagents 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 (SPC) lab reagents from August 2014 because the package insert lists the wrong volume of diluent for reconstitution. This could cause assay errors if users add the incorrect amount of diluent.
The package insert incorrectly states the volume of diluent needed for the master mix tube. When users add the wrong amount of diluent, it can affect the DNA assay results, potentially leading to incorrect test outcomes.
Laboratory users who purchased BD MAX DNA MMK (SPC) reagents with catalog number 442829 since August 2014 are affected. Researchers using these reagents for DNA testing are most at risk of inaccurate results.
Check for BD MAX DNA MMK (SPC) reagents with catalog number 442829 purchased since August 20, 2014. The product is intended for laboratory use only.
Verify the diluent volume listed in the package insert matches the correct amount for the reconstitution process.
The product is safe to use if the correct diluent volume is added as specified in the updated package insert.
The official recall notice does not specify a remedy for this issue.
This recall applies to BD MAX DNA MMK (SPC) reagents purchased since 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-1544-2018 — Becton Dickinson Becton Dickinson Hello, I own a Becton Dickinson that is covered by recall Z-1544-2018 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.
