CLASS II Device recall · Reported 27 May 2015 · FDA Enforcement Report
Lerner Laboratories Mucolexx, 1 pint / &; Shandon Mucolexx recalled
Richard-Allan Scientific is recalling Lerner Laboratories Mucolexx, 1 pint / &; Shandon Mucolexx, distributed nationwide in the US. The recall was initiated on 29 Apr 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1640-2015
- FDA event ID
- 71178
- Recalling firm
- Richard-Allan Scientific, Kalamazoo, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Apr 2015
- FDA classified
- 21 May 2015
- Reported
- 27 May 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 29 Apr 2015 | Recall initiated by company | |
| 21 May 2015 | Classified by FDA | +22 days |
| 27 May 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
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, Japan, Korea, Netherlands, Panama, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and UK.
Nationwide ArkansasArizonaCaliforniaColoradoFloridaGeorgiaIllinoisIndianaKentuckyMassachusettsMinnesotaMissouriMississippiMontanaNorth CarolinaNorth DakotaNew JerseyNevadaNew YorkOhio
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L-Product Codes 44041& 44042. Lot Numbers & EXP Dates: 301362-Jun-2016; 272123-Sep-2015; 317218-Dec-2016; 266312-Jul-2015. Shandon Mucolexx 500ml/0.13gal, 4L/1.06 gal, 120mL , Product Code 9990370, 9990371 & 9990375; Lot Numbers & EXP Dates: 328311-Mar-2017; 324252-Feb-2017; 314543-Dec-2016; 304548-Jul-2016; 289566-Mar-2016; 282598-Dec-2015; 276182-Nov-2015; 267432-Aug-2015; 255776-Apr-2015; 311289-Oct-2016; 299148-Jun-2016; 285035-Feb-2016; 273852-Oct-2015; 263847-Jul-2015; 312363-Oct-2016 & 255325-Apr-2015
Where was it sold?
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, Japan, Korea, Netherlands, Panama, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and UK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 71178| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Mucolytic Agent 1 pint recalled by Richard-Allan Scientific | Richard-Allan Scientific | Other | Nationwide |
More recalls from Richard-Allan Scientific
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | EZ Single Cytofunnel Brown, A78710004 recalled | Richard-Allan Scientific | Labeling Errors | Nationwide |
| Device | CLASS II | Shandon Rapid Chrome Kwik-Diff Kit recalled by Richard-Allan Scientific | Richard-Allan Scientific | Other | 24 states |
| Device | CLASS II | Richard Allan Scientific 10% Neutral Buffered Formalin recalled | Richard-Allan Scientific | Other | 6 states |
| Device | CLASS III | Paraffin Type 3 For in vitro diagnostic use recalled | Richard-Allan Scientific | Temperature Abuse | 12 states |
| Device | CLASS II | Mucolytic Agent 1 pint recalled by Richard-Allan Scientific | Richard-Allan Scientific | Other | Nationwide |
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