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.
BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining.
Leica is recalling its BOND Polymer Refine Detection Kit (DS9800) because it was stored out of refrigeration longer than recommended, which could cause poor staining results in lab tests. This affects pathologists and lab technicians using the kit for tissue analysis.
The kits were held out of refrigerated storage longer than specified, which can lead to suboptimal staining. This means tissue samples might not show clear results when analyzed, potentially affecting diagnostic accuracy.
Pathologists and lab technicians who use the BOND Polymer Refine Detection Kit (DS9800) for in vitro diagnostics are most at risk. The recall applies to kits purchased with lot number 65549.
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.
Look for the lot number 65549 on the packaging to confirm if your kit is affected.
The kits were held out of refrigerated storage longer than specified, which may cause suboptimal staining results in lab tests.
Check the lot number on the packaging. If it's 65549, contact Leica for guidance on next steps.
No, this recall involves potential staining issues, not physical harm. The risk is low and only affects test accuracy.
We’ve drafted a message you can send Leica to request your refund or repair — edit it as you like.
Subject: Recall Z-0673-2020 — Leica Leica Hello, I own a Leica that is covered by recall Z-0673-2020 from Leica. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
