U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Product may fail performance testing for s aureus atcc 43300.
조치
The firm initiated the recall by letter on 05/04/2018. The letter stated the following:
"Please notify any personnel who need to be aware of the potential for failure of performance for this product. Accordingly, in keeping with our Quality Policy, we request that you inspect your stock and destroy any remaining inventory of the lots listed above and contact Customer Services or your local distributor regarding replacement. You should review results and laboratory reporting associated with use of the listed lots and consider retesting and/or seek appropriate expert advice for further action."
For questions contact Technical Services Department at 800-255-6730 or 913-888-0939.
remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN || Product Usage: || Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and oxacillin).