Recall Z-2146-2016 ยท KPA Slide Stainer, Automated
Hardy Diagnostics
QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.
| Date | Jul 8, 2016 (initiated May 24, 2016) |
| Status | Terminated |
| Reason | Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient. |
| Root cause | Under Investigation by firm |
| Action | The firm began notifying consignees via phone on 05/23/16. The firm also sent out Urgent Notification letters, dated June 15, 2016. The firm's phone script instructs customers to decrease the number of rinses on the slide and increasing the number of rinses in the chamber for better outcomes and performance with the instrument. Reducing the rinses on the slide may prevent bacteria from coming off the slide, and adding rinses to the empty chamber will help ensure that the chamber is clean before the next slide is introduced. The firm's customer notification letter recommended an immediate u |
| Quantity | 25 |
| Distribution | U.S. Distribution to the following states: CA, TX, NE, OK, LA, NC, PA, AZ, NY, PA, VA, NM, MI, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.