Home / Recalls / Richard-Allan Scientific Company / Z-2351-2016

Z-2351-2016 Class II Terminated

Recalled by Richard-Allan Scientific Company — Kalamazoo, MI

Recall Details

Product Type
Devices
Report Date
August 17, 2016
Initiation Date
June 13, 2016
Termination Date
November 8, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
18 cases

Product Description

Richard Allan Scientific 10% Neutral Buffered Formalin, Part Number: 53901 and 561201 Item 53901 90ml bottle, 125 per case; Item 561201 120ml bottle, 75 per case.

Reason for Recall

potential contamination with potassium hydroxide may have an impact when performing immunohistochemistry testing. It is unknown whether the contamination will affect tissue antigenicity. If it were to affect tissue antigenicity, the outcome would be risk of false positive or false negative test results which may lead to serious injury. There is the possibility the patient may need to be re-biopsied.

Distribution Pattern

Distributed in the states of FL, PA, NY, MD, CA, and AZ.

Code Information

Item 53901, Lot 371348, exp date 01APR2020; Item 561201, Lot 371355, exp date 01APR2020

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-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-1639-2015 Class II — Mucolytic Agent 1 pint/473 ml; 1 gallon/3.8 l Product Usage: A mucoliquefyin (April 29, 2015)
  • Z-1264-2015 Class III — Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; S (February 19, 2015)
  • Z-0013-2015 Class I — Richard-Allan Scientific Specimen Transportation System. Product Usage: 10% N (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)
  • Z-0017-2015 Class I — Richard-Allan Scientific Specimen Transportation System. 10% NBF is used to s (September 17, 2014)