Leica Biosystems recalls Aperio CS2 CE IVD scanners with part #23CS100CE (serials 5899, 5902, 5986) due to potential incorrect sensor causing image analysis errors and visual issues.
The incorrect sensor was used in the assembly of the camera in the scanner instrument which can potentially generate whole slide images that impact analysis algorithm results, as well as potentially impact the visual appearance of whole slide images.
Leica Biosystems is recalling specific Aperio CS2 CE IVD scanners that may have an incorrect sensor, which could lead to inaccurate image analysis results and visual problems in whole slide images. This affects laboratory users who rely on these scanners for medical imaging.
The scanner may have been assembled with the wrong sensor, which can cause the whole slide images to be inaccurate in terms of analysis results and visual quality. This could lead to misinterpretation of medical data if the images are used for diagnosis.
Laboratory users who own or operate the recalled Aperio CS2 scanners with serial numbers 5899, 5902, or 5986 are most at risk. These scanners are used in medical imaging settings for analyzing tissue samples.
Check if your Aperio CS2 scanner has the part number 23CS100CE and serial numbers 5899, 5902, or 5986. These specific units were identified in the recall.
Verify your scanner's part number and serial number to confirm if it is in the recall list (part #23CS100CE, serials 5899, 5902, 5986).
The recall is due to the potential use of an incorrect sensor during assembly, which may cause inaccurate image analysis results and visual issues in whole slide images.
The official recall notice does not specify a remedy or action for affected scanners. You should check the scanner details to confirm if it is recalled.
Check for part number 23CS100CE and serial numbers 5899, 5902, or 5986 on your Aperio CS2 scanner.
We’ve drafted a message you can send Leica Biosystems to request your refund or repair — edit it as you like.
Subject: Recall Z-0046-2020 — Leica Biosystems Leica Biosystems Hello, I own a Leica Biosystems that is covered by recall Z-0046-2020 from Leica Biosystems. 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.
