Leica Biosystems Recalls BOND Polymer Refine Red Detection Due to Fungal Contamination
Leica Biosystems is recalling BOND Polymer Refine Red Detection kits because they may contain fungal contaminants that can cause staining sensitivity loss or fluid delivery obstructions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a fungal contaminant that affects the performance of the diagnostic reagent (loss of sensitivity or fluid obstruction) rather than causing direct physical injury or infection to patients, fitting the criteria for a moderate severity recall.
Plain-English summary
Leica Biosystems Newcastle Ltd. is recalling specific lots of BOND Polymer Refine Red Detection (Catalog No. DS9390) and BOND Polymer Refine Red Detection (Catalog No. DS9477). The affected lots may contain a fungal contaminant. This contamination can result in a loss of staining sensitivity and/or obstructions to fluid delivery to the slide.
The recall includes 2,304 units of Catalog No. DS9390 (Lot Numbers: 22017, 22139, 22262, 22337, 22411, 22514, 22541) and 37 units of Catalog No. DS9477 (Lot Number: 22250). The product is an in vitro diagnostic reagent used for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system.
The affected products were distributed worldwide, including in the United States and various international locations. Users should stop using the affected lots and contact Leica Biosystems for further instructions.
The recalled product
- Product
- Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; 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…
- Manufacturer
- Leica Biosystems Newcastle Ltd.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- *** 1 ) Catalog Number: DS9390
- Lot Numbers: 22017
- 22139
- 22262
- 22337
- 22411
- 22514
- 22541
- *** 2) Catalog Number: DS9477
- Lot Number: 22250
Distribution
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