Recall Z-0016-2015 ยท LDY Fixative, Formalin-Containing
Richard-Allan Scientific Company
Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
| Date | Oct 9, 2014 (initiated Sep 17, 2014) |
| Status | Terminated |
| Reason | The affected lots could have NBF concentrations that are lower or higher than the desired specifications. |
| Root cause | Mixed-up of materials/components |
| Action | The firm issued an "URGENT MEDICAL DEVICE RECALL" letter to all affected customers. The notification identified the affected products, reason for voluntary recall, risk to health, actions to be taken, and instructions to complete the attached Acknowledgement Form. For questions, contact Sarah Rickert at 269-544-5628 or sarah.rickert@thermofisher.com. |
| Quantity | 199 cases |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.