Recall Z-2328-2019 ยท NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Becton Dickinson & Co.
Kit BD Max MRSA; Catalog # 442953
| Date | Jul 17, 2019 |
| Status | Terminated |
| Reason | The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. |
| Root cause | Process control |
| Action | 1. Thoroughly inspect all foil bags prior to use. If any of the foil bags in your inventory contain holes, dispose of the product and note the quantity in the attached Customer Response Form in order to request replacement. 2. Even if you do not have inventory of the product listed, complete the attached Customer Response Form and return to the BD contact noted on the form so that BD may acknowledge your receipt of this notification. 3. Share this Advisory Letter with all users of the BD MAX instrument within your facility to ensure awareness. 4. Report any adverse health consequences exper |
| Quantity | 176 units |
| Distribution | AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120138 | BD MAX MRSA ASSAY, BD MAX INSTRUMENT Bd Diagnostics (Geneohm Sciences Canada, Inc), Jul 5, 2012 |