Z-0086-2018Class II

NucliSENS Lysis Buffer Extended lot for RES 76675

Name: Z-0086-2018 NucliSENS Lysis Buffer Extended lot for RES 76675
Creator: BioMerieux SA
Published: 2017-10-18
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2017-10-18 / Terminated / root cause: manufacturing process

FDA source

BioMerieux SA began a recall of NucliSENS Lysis Buffer Extended lot for RES 76675 on 2017-10-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0086-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-18
Posted: 2017-11-09
Terminated: 2021-08-24
Recalling firm: bioMerieux, Inc.
Product: NucliSENS Lysis Buffer Extended lot for RES 76675
Product code: PPM General Purpose Reagent
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: US customers were notified on 10/18/2017 via letter using 2-day Fed Ex shipment. Instructions included notifying all appropriate personnel in the laboratory or to customers if product was further distributed, refrain from using the affected product, and arrange for replacement of affected product by completing and returning the response form. It also instructed customers to contact and discuss any concerns regarding previously reported results with the appropriate Laboratory Medical Director to determine an appropriate course of action.
Quantity in commerce: 911 units
Distribution: Distributed domestically to MD, CO, and OH.
Product codes and lots: REF 200292, Lot 17022802, Exp Date 01/28/2019 Extended lot for RES 76675

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0086-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0086-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-15	2017-11-09

Product code PPM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)