Lerner Laboratories Mucolexx — Class II medical device recall Z-1640-2015
Terminated recall by Richard-Allan Scientific Company, reported 2015-05-27, distributed nationwide. Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a customer com
| Recall number | Z-1640-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Richard-Allan Scientific Company, Kalamazoo, MI, United States |
| Recall initiated | 2015-04-29 |
| Classified | 2015-05-21 |
| Reported by FDA | 2015-05-27 |
| Terminated | 2016-03-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | BD, CA, CH, CN, CR, DE, ES, FR, GB, GR, IE, IL, IN, IT, JP, KR, NL, PA, PL, PT, SA, SE, TH, TR, ZA |
| Reason classes | microbial contamination |
| Pathogens | mold |
| Lot numbers | 255325-APR-2015, 255776-APR-2015, 263847-JUL-2015, 266312-JUL-2015, 267432-AUG-2015, 272123-SEP-2015, 273852-OCT-2015, 276182-NOV-2015, 282598-DEC-2015, 285035-FEB-2016, 289566-MAR-2016, 299148-JUN-2016, 301362-JUN-2016, 304548-JUL-2016, 311289-OCT-2016, 312363-OCT-2016, 314543-DEC-2016, 317218-DEC-2016, 324252-FEB-2017, 328311-MAR-2017 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1640-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.