Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CS011 GNR PNA FISH Control Slide Recalled by Opgen Inc Due to May show diminished performance prior to its established...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Opgen Inc directly.
Affected Products
CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit . In-Vitro Diagnostic The CS011 GNR Traffic Light Control Slide provides a positive and negative control for the KT011 GNR Traffic Light PNA FISH kit. GNR Traffic Light PNA FISH provides rapid identification of E. coli, K. pneumoniae and P. aeruginosa directly from Gram-negative blood cultures
Quantity: 80 slides
Why Was This Recalled?
May show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test
Where Was This Sold?
This product was distributed to 3 states: CT, MI, VA
About Opgen Inc
Opgen Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report