Home / Recalls / Richard-Allan Scientific Company / Z-0013-2015

Z-0013-2015 Class I Terminated

Recalled by Richard-Allan Scientific Company — Kalamazoo, MI

Recall Details

Product Type
Devices
Report Date
October 15, 2014
Initiation Date
September 17, 2014
Termination Date
October 27, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
285 cases

Product Description

Richard-Allan Scientific Specimen Transportation System. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

Reason for Recall

The affected lots could have NBF concentrations that are lower or higher than the desired specifications.

Distribution Pattern

Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.

Code Information

Product Code: 534801 Lot Number: 296986

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  • 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-1639-2015 Class II — Mucolytic Agent 1 pint/473 ml; 1 gallon/3.8 l Product Usage: A mucoliquefyin (April 29, 2015)
  • 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-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)
  • Z-0017-2015 Class I — Richard-Allan Scientific Specimen Transportation System. 10% NBF is used to s (September 17, 2014)