Leica BIOSYSTEMS — Class II medical device recall Z-0717-2014
Terminated recall by Leica Biosystems Newcastle Ltd., reported 2014-01-22, distributed in AL, AR, AZ, CA, CO, CT, DE, FL…. The affected lots of the product may contain a contaminant of fungus that can cause a loss of staining sensiti
| Recall number | Z-0717-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leica Biosystems Newcastle Ltd., Newcastle Upon Tyne, United Kingdom |
| Recall initiated | 2013-07-31 |
| Classified | 2014-01-10 |
| Reported by FDA | 2014-01-22 |
| Terminated | 2017-08-14 |
| Distributed | 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, WV |
| Countries outside the US | CH, CL, DE, DK, FI, FR, GB, IE, IT, KR, NL, PL, RO, SE, SG |
| Reason classes | microbial contamination |
| Pathogens | mold |
| Lot numbers | 22017, 22139, 22250, 22262, 22337, 22411, 22514, 22541 |
| Model numbers | DS9390, DS9477 |
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 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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0717-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.