Opgen Inc: Medical Device Recall in 2019 - (Recall #: Z-1328-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 18, 2019

Date Posted: May 22, 2019

Recall Number: Z-1328-2019

Event ID: 82665

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

Status: Terminated

Product Quantity: 80 slides

Code Information:

Lot Number FN80107

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated