Home / Recalls / Richard-Allan Scientific Company / Z-1319-2016

Z-1319-2016 Class III Terminated

Recalled by Richard-Allan Scientific Company — Kalamazoo, MI

Recall Details

Product Type
Devices
Report Date
April 13, 2016
Initiation Date
February 16, 2016
Termination Date
August 23, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
29 cases (10 bags per case)

Product Description

Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use. For use as an infiltration and embedding medium in histology. Thermo Scientific" Richard-Allan Scientific" Type 1, Type 3, Type 6, and Type 9 Paraffin is specifically designed for tissue processing and embedding of histological and cytological specimens. The product is a white solid at room temperature and a clear, colorless liquid when molten. The paraffin is highly quality controlled and can be used with both open and closed tissue processors. It is also compatible with all embedding centers and manual embedding techniques. The paraffin should be stored in a cool, dry place

Reason for Recall

Multiple complaints were received from customers indicating that they ordered product 8335(Type 3 Paraffin) but when they opened the box, they found product 8336 (Type 6 Paraffin) inside.

Distribution Pattern

Worldwide distribution to AZ , CA , FL , GA , IL , MI , MN , NM , NY , OH , TX , UT and Internationally to Germany and the United Kingdom. 6 distributed to OUS accounts: Germany, and the United Kingdom

Code Information

Product code: 8335 and lot code: 348248

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  • 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)
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  • Z-0017-2015 Class I — Richard-Allan Scientific Specimen Transportation System. 10% NBF is used to s (September 17, 2014)