CLASS III Device recall · Reported 9 May 2018 · FDA Enforcement Report

BD MAX DNA MMK (SPC) For Laboratory Use recalled by Becton Dickinson &

Becton Dickinson & is recalling BD MAX DNA MMK (SPC) For Laboratory Use, distributed nationwide in the US. The recall was initiated on 2 Mar 2018 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesAll since 08/20/2014

Quantity recalled13,898

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1544-2018
FDA event ID: 79769
Recalling firm: Becton Dickinson &, Sparks, MD
Classification: Class III
Status: Terminated
Recall initiated: 2 Mar 2018
FDA classified: 28 Apr 2018
Reported: 9 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Other Medical Devices

Timeline

2 Mar 2018	Recall initiated by company
28 Apr 2018	Classified by FDA	+57 days
9 May 2018	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829

Where it was distributed

Distributed to accounts in 8 states: CA, FL, NJ, NY, OR, PA, VA, and WI. International distribution to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Europe, Hong Kong, Japan, Singapore, Taiwan, and Thailand.

Nationwide California Florida New Jersey New York Oregon Pennsylvania Virginia Wisconsin

Questions about this recall

Is BD MAX DNA MMK (SPC) For Laboratory Use recalled?

Yes. Becton Dickinson & recalled BD MAX DNA MMK (SPC) For Laboratory Use on 2 Mar 2018. The recall is Class III and its status is Terminated. Recall number Z-1544-2018.

Why was it recalled?

Which lots are affected?

All since 08/20/2014

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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