CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit . In-Vitro Diagnostic T...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1328-2019.
May show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1328-2019.
Recall terminated by FDA.
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- Do not stop, change, or discard your prescription on your own.
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- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1328-2019.
Opgen Inc
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Opgen Inc Recall FAQ
Opgen Inc is the subject of a diagnostic devices safety report: CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit . In-Vitro Diagnostic T.... The notice was published on March 18, 2019 by the U.S. Food and Drug Administration (FDA). Approximately 80 units are potentially affected.