Z-0443-2019 Class II Terminated
FDA device recall Z-0443-2019 was initiated by bioMerieux, Inc. on Oct 8, 2018 and is designated Class II. Reason for recall: Some eluates become colored because of remaining hemoglobin in the eluate. The recall status is terminated (terminated May 21, 2021). Affected quantity: 268.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 21, 2018
- Initiation Date
- Oct 8, 2018
- Termination Date
- May 21, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 268
Product Description
bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134
Reason for Recall
Some eluates become colored because of remaining hemoglobin in the eluate.
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
Code Information
Lot Z019EA1LB Exp. 28-MAY-2019.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0443-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026