CLASS II Device recall · Reported 21 Nov 2018 · FDA Enforcement Report

bioM¿rieux NucliSENS easyMAG Lysis Buffer recalled by bioMerieux

bioMerieux is recalling bioM¿rieux NucliSENS easyMAG Lysis Buffer, distributed in 19 states. The recall was initiated on 8 Oct 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Z019EA1LB Exp. 28-MAY-2019.

Quantity recalled268

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-0443-2019
FDA event ID: 81323
Recalling firm: bioMerieux, Durham, NC
Classification: Class II
Status: Terminated
Recall initiated: 8 Oct 2018
FDA classified: 9 Nov 2018
Reported: 21 Nov 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

8 Oct 2018	Recall initiated by company
9 Nov 2018	Classified by FDA	+32 days
21 Nov 2018	Published in enforcement report	+12 days

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

Reason for recall

Some eluates become colored because of remaining hemoglobin in the eluate.

Product as listed by the FDA

bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134

Where it was distributed

CA, FL, GA, MD, MI, MN, NC, NJ, NM, NY, OH, OR, RI, SC, TN, TX, VA, WA, and WI Austria, Australia, Belgium, Switzerland, Colombia, Germany, Spain, France, UK, India, Italy, Japan, Netherlands, Portugal, Sweden, Singapore, South Africa, Israel, Dutch Antilles, Angola, Estonia, and Bangladesh

California Florida Georgia Maryland Michigan Minnesota North Carolina New Jersey New Mexico New York Ohio Oregon Rhode Island South Carolina Tennessee Texas Virginia Washington Wisconsin

Questions about this recall

Why was it recalled?

Some eluates become colored because of remaining hemoglobin in the eluate.

Which lots are affected?

Lot Z019EA1LB Exp. 28-MAY-2019.

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 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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