Richard Allan Scientific Recalls Mucolytic Agent Due to Fungal Contamination
Richard Allan Scientific is recalling Mucolytic Agent and Mucolexx after a customer complaint reported fungal contamination in two lots of Mucolexx.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a Class II medical device with a report of fungal contamination. While no illnesses or injuries are explicitly reported in the source text, the presence of a biological contaminant in a medical product used for diagnostic specimens represents a risk of harm, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Richard Allan Scientific (RAS) is initiating a recall of Mucolytic Agent and Mucolexx. This action follows a customer complaint reporting that a laboratory found fungal contamination in two lots of Mucolexx.
The recalled products are mucoliquefying preservatives designed for use in the preparation of mucoid cytology specimens. The specific products involved are Mucolytic Agent in 1 pint (473 ml) and 1 gallon (3.8 l) sizes, as well as Mucolexx. The recall covers specific lot numbers and expiration dates listed in the agency's structured data, distributed worldwide and across numerous US states.
Healthcare facilities and laboratories should stop using the affected lots immediately. Consumers and medical professionals should check their inventory for the specific product codes and lot numbers identified in the recall notice and contact the manufacturer or their supplier for instructions on return or disposal.
The recalled product
- Product
- 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.
- Manufacturer
- Richard-Allan Scientific Company
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- Richard Allan Scientific Mucolytic Agent 1 pint / 473 ml Product code: 76166
- Lot #s and EXP Dates: 313839-Dec 2016
- 311157-Oct-2016
- 306726-Aug-2016
- 297142-Jun-2016
- 296289-May-2016
- 290486-Mar-2016
- 289488-Mar-2016
- 276824-Nov-2015
- 271110-Oct-2015
- 265368-Aug-2015. Richard Allan Scientific Mucolytic Agent 1 gallon/ 3.8 l
- Product Code: 76167
- Lot Number & EXP Dates: 311158- Oct-2016
- 302099- Jun-2016
- 298834-Jun-2016
- 293734- Apr-2016
- 288009-Feb-2016
- 283396-Jan-2016
- 279581-Nov-2015
Distribution
Part of a larger recall action
This product is one of 2 recalled by Richard-Allan Scientific Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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