Reported Jan 22, 2014 · Terminated
Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leica Biosystems Newcastle Ltd; Balliol…
Leica Biosystems Newcastle Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Leica Biosystems Newcastle Ltd. · Balliol Business Park West, · Newcastle Upon Tyne · N/A
Is this the product you have?
- Leica BIOSYSTEMS; BOND Polymer Refine Red Detection
- Catalog NoDS9390; Leica Biosystems Newcastle Ltd; Balliol Business Park West; Benton Lane; Newcastle Upon Tyne NE12 8EW; United Kingdom; www.LeicaBiosystems.com; Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphate (AP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. This detection system is for in vitro diagnostic use. Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system. The clinical interpretation of any staining or its absence should be complemented by morphological studies. Proper controls should be evaluated within the context of the patients clinical history and other diagnostic tests by a qualified pathologist. The Bond Polymer Refine Red Detection must be used with laboratory best practice in the use of tissue controls. For assurance, laboratories should stain each patient sample in conjunction with positive, negative and other tissue specific controls as needed
- Lot codes and dates
- *** 1 )
- Catalog NumberDS9390
- Lot Numbers
22017221392226222337224112251422541*** 2)
- Catalog NumberDS9477
- Lot Number22250
- Amount recalled
- 1) 2,304 units; 2) 37 units
Where it was sold
Why it was recalled
The affected lots of the product may contain a contaminant of fungus that can cause a loss of staining sensitivity and/or obstructions to fluid delivery to the slide.
This product could cause temporary or reversible health problems — stop using it.
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