CLASS II Device recall · Reported 31 Oct 2018 · FDA Enforcement Report

NucliSENS¿ Magnetic Extraction Reagents recalled by BioMerieux

BioMerieux is recalling NucliSENS¿ Magnetic Extraction Reagents, distributed nationwide in the US. The recall was initiated on 17 Sep 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesReference # 200293, Lot # 17121501, Expiration date 11/28/2018

Quantity recalled42 units

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-0218-2019
FDA event ID: 81067
Recalling firm: BioMerieux, Marcy L'Etoile, N/A
Classification: Class II
Status: Terminated
Recall initiated: 17 Sep 2018
FDA classified: 23 Oct 2018
Reported: 31 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Device type: Test Kits & Diagnostics

Timeline

17 Sep 2018	Recall initiated by company
23 Oct 2018	Classified by FDA	+36 days
31 Oct 2018	Published in enforcement report	+8 days

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

Reason for recall

Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

NucliSENS¿ Magnetic Extraction Reagents

Where it was distributed

Nationwide distribution to MD, TX, MA, GA, OH, OR, CA, and WA.

Nationwide California Georgia Massachusetts Maryland Ohio Oregon Texas Washington

Questions about this recall

Why was it recalled?

Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product.

Which lots are affected?

Reference # 200293, Lot # 17121501, Expiration date 11/28/2018

Where was it sold?

Nationwide distribution to MD, TX, MA, GA, OH, OR, CA, and WA.

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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