Leica Biosystems recall
Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leica Biosystems Newcastle Ltd; Balliol Business Park West; Benton Lane…
Why was Leica Biosystems 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
*** 1 ) Catalog Number: DS9390; Lot Numbers: 22017, 22139, 22262, 22337, 22411, 22514, 22541; *** 2) Catalog Number: DS9477; Lot Number: 22250
- Product
- Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leica Biosystems Newcastle Ltd; Balliol Business Park West; Benton Lane…
- Recalling firm
- Leica Biosystems Newcastle Ltd.
- Quantity
- 1) 2,304 units; 2) 37 units
- Distribution
- Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, and WV); and Internationally to Chile, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Sweden, Switzerland, Poland, Romania, Singapore, South Korea, and the United Kingdom.
- Recall date
- January 22, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)