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Recall Observatory FDA recall evidence

Device product

bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134

Z-0443-2019

October 08, 2018

Class II

Product summary

Firm
bioMerieux, Inc.
Event
Event 81323
Status
Terminated
Classification
Class II
Quantity
268
Official record key
device-enforcement:Z-0443-2019

Official wording

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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