Remel recalls SWIN 2017 database Model YSW4000 due to potential for out of range microbial results. Affected units may need to be returned or disposed of.
Potential for out of range microbial results
Remel is recalling its SWIN 2017 database Model YSW4000 because it may produce microbial test results outside the expected range. This could lead to inaccurate health assessments if used for medical testing.
The device may produce microbial test results that fall outside the intended range. This could cause inaccurate health assessments if used for medical testing, potentially leading to incorrect health decisions.
Users of the SWIN 2017 database Model YSW4000 for medical testing are likely affected. Healthcare professionals and labs using this device for microbial analysis are at the highest risk.
Check for the SWIN 2017 database Model YSW4000 label. This product was sold by Remel, Inc. in 2017.
Look for the SWIN 2017 database Model YSW4000 label on the device.
The product may produce microbial test results outside the intended range, potentially leading to inaccurate health assessments.
Check for the SWIN 2017 database Model YSW4000 label. This product was sold by Remel, Inc. in 2017.
The recall record does not specify a remedy, so contact Remel, Inc. for further instructions.
We’ve drafted a message you can send Remel to request your refund or repair — edit it as you like.
Subject: Recall Z-1939-2020 — Remel Remel Hello, I own a Remel that is covered by recall Z-1939-2020 from Remel. 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.
