Reported Nov 15, 2017 · Terminated

NucliSENS Lysis Buffer Extended lot for RES 76675

BioMerieux SA

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: BioMerieux SA · Chemin De L'Orme · Marcy L'Etoile, N/A · N/A

Is this the product you have?

  • NucliSENS Lysis Buffer Extended lot for RES 76675
Lot codes and dates
  • REF 200292, Lot 17022802, Exp Date 01/28/2019 Extended lot for RES 76675
Amount recalled
911 units

Where it was sold

Why it was recalled

Elute may become colored due to the residual presence of heme group origination from hemoglobin present in whole blood samples as well as dried spot (DBS) samples. This can potentially cause the inhibition of PCR reactions and result in an uninterpretable test result. If using an Internal Control (IC) in the extraction process the IC could potentially be inhibited as well and invalidate test results.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new BioMerieux SA recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 24, 2021 · Data as of Sep 19, 4:47 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.