Recall Z-1640-2015— Richard-Allan Scientific Company
Class II · Terminated
Class II FDA medical device recall by Richard-Allan Scientific Company, initiated 2015-04-29, terminated 2016-03-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L; Shandon Mucolexx 500ml/0.13gal, 4L/1.06 gal, 120mL 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.. 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..
- Recalling firm
- Richard-Allan Scientific Company
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-29
- Terminated
- 2016-03-09
- Firm location
- Kalamazoo, MI, United States
Product description
Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L; Shandon Mucolexx 500ml/0.13gal, 4L/1.06 gal, 120mL 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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.