Z-0443-2019Class II

bioMrieux NucliSENS easyMAG Lysis Buffer ref. 280134

Name: Z-0443-2019 bioMrieux NucliSENS easyMAG Lysis Buffer ref. 280134
Creator: bioMerieux, Inc.
Published: 2018-10-08
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2018-10-08 / Terminated / root cause: manufacturing process

FDA source

bioMerieux, Inc. began a recall of bioMrieux NucliSENS easyMAG Lysis Buffer ref. 280134 on 2018-10-08. FDA classified it as Class II and gives the reason as "Some eluates become colored because of remaining hemoglobin in the eluate". 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-0443-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-08
Posted: 2018-11-09
Terminated: 2021-05-21
Recalling firm: bioMerieux, Inc.
Product: bioMrieux NucliSENS easyMAG Lysis Buffer ref. 280134
Product code: PPM General Purpose Reagent
Reason for recall: Some eluates become colored because of remaining hemoglobin in the eluate.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Required Actions We request you to take the following actions at this time: -Please distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred our product. -Stop using the NUCLISENS Lysis Buffer, Ref. 280134, Lot: Z019EA1LB, exp. 28-MAY-2019, and destroy any stock of this lot Z019EA1LB you might have in your laboratory. -Discuss any concern you may have regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action. -Contact your local bioMerieux, Inc. Customer Service representative if you have observed the issue and if you have a doubt regarding your results. -Complete the attached Acknowledgement Form in Attachment A to confirm receipt of this notice and return it to your local bioMrieux, Inc. representative. bioMrieux, Inc. is committed to providing our customers with the highest quality product possible. We sincerely apologize for any inconvenience that this may have caused your business. If you require additional assistance or have any questions, please contact your local bioMrieux, Inc. Clinical Customer Service representative at (800) 682-2666 or Industry Customer Service representative at (800) 634-7656. For non-urgent inquiries, please contact the Clinical Technical Support Center by email at [email protected]. The anticipated turnaround time for email inquiries is 24-48 hours during normal business hours (7AM 7PM EST), and up to 72 hours dependent upon weekends and company observed holidays.
Quantity in commerce: 268
Distribution: CA, FL, GA, MD, MI, MN, NC, NJ, NM, NY, OH, OR, RI, SC, TN, TX, VA, WA, and WI Austria, Australia, Belgium, Switzerland, Colombia, Germany, Spain, France, UK, India, Italy, Japan, Netherlands, Portugal, Sweden, Singapore, South Africa, Israel, Dutch Antilles, Angola, Estonia, and Bangladesh
Product codes and lots: Lot Z019EA1LB Exp. 28-MAY-2019.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0443-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0443-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-21	2018-11-09

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)