FDA recall Z-0443-2019

Product

bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134

Reason for recall

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

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

Key facts

Status

Terminated

Initiation date

2018-10-08

Report date

2018-11-21

Termination date

2021-05-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Durham, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0443-2019