Recall Z-1639-2015 ยท LEA Preservative, Cytological
Richard-Allan Scientific Company
Mucolytic Agent 1 pint/473 ml; 1 gallon/3.8 l Product Usage: A mucoliquefying preservative designed for use in the preparation of mucoid cytology specimens. Mucolexx & Mucolytic Agent liquefies mucus and allows for optimal cytologic diagnostic results.
| Date | May 21, 2015 (initiated Apr 29, 2015) |
| Status | Terminated |
| Reason | Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a customer complaint reporting that a lab had found fungal contamination in 2 lots of Mucolexx. |
| Root cause | Material/Component Contamination |
| Action | Richard Allan Scientific (RAS) initiated a voluntary recall of Mucolexx and Mucolytic Agent due to fungal contamination on 5/1/2015 via certified mail to all customers who received the affected. Customers were asked to return a repsonse form, and dispose or return all recalled products. Please contact Sarah Rickert at 269-544-5628 or sarah.rickert@thermofisher |
| Quantity | Product 76166- 116; Product Code 76167-29 |
| Distribution | Worldwide Distribution - US Nationwide in the states of: AR; AZ; CA; CO; FL; GA; I A; IL; IN; KY; MA; MN; MO; MS; MT; NC; ND; NJ; NV; NY; OH; OK; PA; PR; SD; TN; TX; VA; WA; WI and the countries of: Bangladesh, Canada, China, Costa Rica, Dubai, France, Germany, Greece, India, Ireland, Israel, Italy |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.