Recall Z-0449-2015 ยท JTS Stains, Microbiologic
Remel Inc
Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A stain for use in qualitative procedures as a counterstain in the fluorescent microscopic detection of mycobacteria.
| Date | Nov 25, 2014 (initiated Oct 29, 2014) |
| Status | Terminated |
| Reason | The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease. |
| Root cause | Process control |
| Action | Thermo Fisher Scientific sent a Medical Device Recall letter dated October 29, 2014, to all affected customers. The letter notified customers that Remel, Inc., a part of Thermo Fisher Scientific, was voluntarily recalling the affected product. Customers were instructed to notify any personnel who need to be notified of the potential for false negative results. Customers should review results reported using this lot and consider retesting and/or seek appropriate expert advice. Return the attached Medical Device Recall Return Response form acknowledging receipt of the notice and disposal of |
| Quantity | 79/5/250- packages/bottles/ml |
| Distribution | Worldwide Distribution to USA including AL, CA, CO, IA, MO, NC, NY, NV, OH, PA, SC, SD, TN, TX, VA, WI and Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.