bioMerieux, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0443-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134

Product Classification:

Class II

Date Initiated: October 8, 2018

Date Posted: November 21, 2018

Recall Number: Z-0443-2019

Event ID: 81323

Reason for Recall:

Some eluates become colored because of remaining hemoglobin in the eluate.

Status: Terminated

Product Quantity: 268

Code Information:

Lot Z019EA1LB Exp. 28-MAY-2019.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated