Recall Z-0443-2019 ยท PPM General Purpose Reagent
bioMerieux, Inc.
bioMrieux NucliSENS easyMAG Lysis Buffer ref. 280134
| Date | Oct 8, 2018 |
| Status | Terminated |
| Reason | Some eluates become colored because of remaining hemoglobin in the eluate. |
| Root cause | Nonconforming Material/Component |
| Action | Required Actions We request you to take the following actions at this time: -Please distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred our product. -Stop using the NUCLISENS Lysis Buffer, Ref. 280134, Lot: Z019EA1LB, exp. 28-MAY-2019, and destroy any stock of this lot Z019EA1LB you might have in your laboratory. -Discuss any concern you may have regarding previously reported results with your Laboratory Medical Director |
| Quantity | 268 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.