Opgen recalls CS011 GNR PNA FISH Control Slide kits for possible diminished performance before expiration, leading to invalid test results for E. coli detection. Affected kits may need replacement to ensure accurate diagnostic results.
May show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test
Opgen is recalling CS011 GNR PNA FISH Control Slides that may show reduced performance before their expiration date, causing invalid test results for detecting E. coli and other bacteria. This could lead to inaccurate diagnostic outcomes if used in the GNR Traffic Light PNA FISH kit.
The control slide may not function properly before its expiration date, leading to invalid test results. This could cause inaccurate identification of harmful bacteria like E. coli in blood cultures, potentially affecting diagnosis and treatment decisions.
Users of the CS011 GNR PNA FISH Control Slide kit for in-vitro diagnostics, particularly those testing blood cultures for E. coli, K. pneumoniae, and P. aeruginosa. Laboratory staff and healthcare professionals using the kit are most at risk.
Check for the CS011 GNR PNA FISH Control Slide as part of the CS011-10 GNR PNA FISH Control Slide kit. The product is used in in-vitro diagnostics for detecting E. coli, K. pneumoniae, and P. aeruginosa in blood cultures.
Verify the expiration date on the control slide to ensure it hasn't expired before use.
If the control slide shows diminished performance, replace it with a new one to maintain accurate test results.
The control slide may show diminished performance before its expiration date, leading to invalid test results for detecting E. coli, K. pneumoniae, and P. aeruginosa.
Using a control slide that has diminished performance could result in inaccurate test results, which might affect diagnosis and treatment decisions for infections.
The product is the CS011 GNR PNA FISH Control Slide, part of the CS011-10 GNR PNA FISH Control Slide kit used for in-vitro diagnostics.
We’ve drafted a message you can send Opgen to request your refund or repair — edit it as you like.
Subject: Recall Z-1328-2019 — Opgen Opgen Hello, I own a Opgen that is covered by recall Z-1328-2019 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.
