The Recall Desk
ModerateFDA (Devices)·Z-0717-2014·Announced 2014-01-22

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.

What this means for you

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 a
Manufacturer
Leica Biosystems Newcastle Ltd.
Category
Medical Device — In Vitro Diagnostic Reagent
Hazard

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

Distributed in 40 states:

Related recalls

Same hazard · fungal contamination

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