Home / Recalls / Richard-Allan Scientific Company / Z-1639-2015

Z-1639-2015 Class II Terminated

Recalled by Richard-Allan Scientific Company — Kalamazoo, MI

FDA device recall Z-1639-2015 was initiated by Richard-Allan Scientific Company on April 29, 2015 and is designated Class II. 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. The recall status is terminated (terminated March 9, 2016). Affected quantity: Product 76166- 116; Product Code 76167-29.

Recall Details

Product Type
Devices
Report Date
May 27, 2015
Initiation Date
April 29, 2015
Termination Date
March 9, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Product 76166- 116; Product Code 76167-29

Product Description

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.

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.

Distribution Pattern

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.

Code Information

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; and 274814- Oct-2015 Dec-2016 Oct-2016 Aug-2016 Jun-2016 May-2016 Mar-2016 Mar-2016 Nov-2015 Oct-2015 Aug-2015

Other recalls by Richard-Allan Scientific Company

  • Z-2749-2018 Class III — EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofunne (June 4, 2018)
  • Z-1895-2017 Class II — Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 Shandon Rapid Chrome Kw (March 15, 2017)
  • Z-2351-2016 Class II — Richard Allan Scientific 10% Neutral Buffered Formalin, Part Number: 53901 and (June 13, 2016)
  • Z-1319-2016 Class III — Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use. For use a (February 16, 2016)
  • Z-1640-2015 Class II — Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L; Shandon Mucolex (April 29, 2015)
  • Z-1264-2015 Class III — Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; S (February 19, 2015)
  • Z-0017-2015 Class I — Richard-Allan Scientific Specimen Transportation System. 10% NBF is used to s (September 17, 2014)
  • Z-0016-2015 Class I — Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NB (September 17, 2014)
  • Z-0018-2015 Class I — Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is use (September 17, 2014)
  • Z-0014-2015 Class I — Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NB (September 17, 2014)

FDA data resources