Z-1713-2017Class II

NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the release of total...

Name: Z-1713-2017 NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the release of total...
Creator: BioMerieux SA
Published: 2017-03-07
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2017-03-07 / Terminated

FDA source

BioMerieux SA began a recall of NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the release of total nucleic acid from biological specimens on 2017-03-07. FDA classified it as Class II and gives the reason as "Problem with colored eluates for whole blood extractions". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1713-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-07
Posted: 2017-03-19
Terminated: 2020-08-18
Recalling firm: bioMerieux, Inc.
Product: NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the release of total nucleic acid from biological specimens
Product code: PPM General Purpose Reagent
Reason for recall: Problem with colored eluates for whole blood extractions
FDA root cause: Under Investigation by firm
Action: BioMerieux sent an Urgent Product Safety Correction Notice to all affected customers electronically on March 7, 2017. US customers will be sent a separate letter. The letter requested that they discard the product and notify all customers that use the product. The notification included a reply form to be returned. Customers with questions were instructed to contact their local bioMerieux Customer Service representative. For questions regarding this recall call 314-731-7301.
Quantity in commerce: 1025
Distribution: Worldwide Distribution - US including IL, OH, WA, and Internationally to Argentina, Australia, Brazil, Chile, Columbia, France, Hong Kong, Italy, Netherlands, Peru, Spain, Uganda, United Kingdom, and Zimbabwe.
Product codes and lots: Lot Number 16092902

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1713-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1713-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-04

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)