Opgen recalls AdvanDx QuickFISH Slides (lot 17306401) that may not perform correctly after their November 2018 expiration date. Consumers should check if their slides expire before November 2018.
Possible diminished performance prior to its established expiration date.
Opgen is recalling AdvanDx QuickFISH Slides that may not work properly after their expiration date of November 2018. This could lead to inaccurate test results if used beyond the expiration date.
The slides may not function correctly after their expiration date, which could lead to inaccurate test results when used with QuickFISH BC culture identification kits. This is a time-based issue related to the product's shelf life.
Users of the QuickFISH BC Fixation Kit who purchased the slides with lot number 17306401 between the product's release and November 2018 are affected. Those using the slides after their expiration date are at higher risk of inaccurate test results.
Check for lot number 17306401 on the slides. The product was sold with an expiration date of November 2018.
Look for the expiration date on the slides; if it is November 2018 or earlier, they may not perform correctly after this date.
No, but if the slides expired before November 2018, they may not work correctly. Check the expiration date first.
If your slides expired before November 2018, they may not perform correctly. Check the expiration date and consider replacing them if needed.
The recall is for potential performance issues, not safety risks. Using expired slides could lead to inaccurate test results but not physical harm.
We’ve drafted a message you can send Opgen to request your refund or repair — edit it as you like.
Subject: Recall Z-2439-2018 — Opgen Opgen Hello, I own a Opgen that is covered by recall Z-2439-2018 from Opgen. 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.
