Device product
bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134
Z-0443-2019
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
Some eluates become colored because of remaining hemoglobin in the eluate.