# FDA recall Z-1328-2019

> **Opgen Inc** · Class II · device recall initiated 2019-03-18.

## Product

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

## Reason for recall

May show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test

## Distribution

US Distribution to states of: CT, MI and VA.

## Key facts

- **Recall number:** Z-1328-2019
- **Recalling firm:** Opgen Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-18
- **Report date:** 2019-05-22
- **Termination date:** 2019-08-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gaithersburg, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1328-2019

## Citation

> AI Analytics. FDA recall Z-1328-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1328-2019. Source: US FDA. Licensed CC0.

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