Z-1365-2020Class II

NUCLISENS Lysis Buffer, IVD, REF 200292, 48X2 ML LYS Manufacturer bioMerieux SA 376, Chemin de l'Orme 69280...

Name: Z-1365-2020 NUCLISENS Lysis Buffer, IVD, REF 200292, 48X2 ML LYS Manufacturer bioMerieux SA 376, Chemin de l'Orme 69280...
Creator: BIOMERIEUX - Grenoble
Published: 2020-01-10
License: https://open.fda.gov/license/

BIOMERIEUX SA - Grenoble / initiated 2020-01-10 / Terminated / root cause: manufacturing process

FDA source

BIOMERIEUX - Grenoble began a recall of NUCLISENS Lysis Buffer, IVD, REF 200292, 48X2 ML LYS Manufacturer bioMerieux SA 376, Chemin de l'Orme 69280 Marcy-l'Etoile - France - Product Usage: to be used... on 2020-01-10. FDA classified it as Class II and gives the reason as "Following a customer complaint about colored eluates, leading to invalid results bioMerieux has confirmed an issue with NUCLISENS Lysis Buffer, ref. 200292, lot 19040201. The issue is linked to drift of pH electrode...". 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-1365-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-10
Posted: 2020-02-11
Terminated: 2022-04-14
Recalling firm: BIOMERIEUX SA - Grenoble
Product: NUCLISENS Lysis Buffer, IVD, REF 200292, 48X2 ML LYS Manufacturer bioMerieux SA 376, Chemin de l'Orme 69280 Marcy-l'Etoile - France - Product Usage: to be used for the release of total nucleic acid from biological specimens.
Product code: PPM General Purpose Reagent
Reason for recall: Following a customer complaint about colored eluates, leading to invalid results bioMerieux has confirmed an issue with NUCLISENS Lysis Buffer, ref. 200292, lot 19040201. The issue is linked to drift of pH electrode dysfunction.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Consignees notified via FedEx Express 2 day delivery service with recall letter dated 10 January 2020. The letter identified affected product, stated reason for recall, and requested product to not be used for testing of whole blood samples containing blood and other specimens containing blood. Samples with no hemoglobin are not impacted by the issue and can be used with expected performance. A Recall Acknowledgement Form was requested to be completed and returned via fax.
Quantity in commerce: 1024
Distribution: No US distribution. No Mexican consignees. International distribution to South Africa, Uruguay, Tanzania, Romania, Netherlands, Macao, Italy, India, Hong Kong, United Kingdom, France, Spain, Germany, China, Chile, Canada, Belgium, Australia, Argentina, Curacao.
Product codes and lots: Lot 19040201, Expiry 28-Feb-2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1365-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1365-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-26

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)