Lower riskMedical device recall · FDA · Published November 18, 2019
Leica BOND Polymer Refine Detection Kit Recall: Suboptimal Staining Risk
Leica recalls BOND Polymer Refine Detection Kit (DS9800) due to potential suboptimal staining from prolonged refrigeration. Affected kits may not stain tissue properly in lab use.
“Leica BOND Polymer Refine Detection Kit Recall: Suboptimal Staining Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66503-leica-bond-polymer-refine-detection-kit-recall-suboptimal-staining-risk. Based on FDA recall #Z-0673-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0673-2020%22&limit=1).
The FDA announced on November 18, 2019, that Leica Microsystems, Inc. is recalling the BOND Polymer Refine Detection Kit, Catalog No. DS9800. The hazard involves kits held out of refrigerated storage longer than specified, which may exhibit suboptimal staining.
How to tell if you have it
Brand: Leica
Product: BOND Polymer Refine Detection Kit
Catalog No.: DS9800
Lot: 65549
Quantity: 558 units
The hazard
The BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining. The detection system is for in vitro diagnostic use.
Context
GovInfoNow's records show Leica Microsystems, Inc. has 15 other recalls on record since June 19, 2017. Other recent recalls include the Leica Proveo 8 Surgical Microscope (November 21, 2022), Leica Surgical Microscopes (August 26, 2022), and Leica M220 F12 Microscope Systems (November 3, 2021). Other recent recalls of similar products include Medline convenience kits with Bard Silastic catheters (June 8, 2026), Medline Convenience Kits (June 12, 2026), and Medline convenience kits with Bard Silastic Foley Catheters (June 8, 2026).
How to tell if you have this one
Check for the catalog number DS9800 on the kit packaging. The affected lot number is 65549. This recall applies to kits used with the BOND automated system for tissue staining.
Brand
Leica
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Number
Look for the lot number 65549 on the packaging to confirm if your kit is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Nationwide and OUS to Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 30 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0673-2020 (November 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0673-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.