Z-1328-2019Class II

CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit...

Name: Z-1328-2019 CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit...
Creator: Opgen Inc
Published: 2019-03-18
License: https://open.fda.gov/license/

Opgen Inc / initiated 2019-03-18 / Terminated

FDA source

Opgen Inc began a recall of 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... on 2019-03-18. FDA classified it as Class II and gives the reason as "May show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1328-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-18
Posted: 2019-05-14
Terminated: 2019-08-05
Recalling firm: Opgen Inc
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
Product code: LJG Quality Control Slides
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
FDA root cause: Under Investigation by firm
Action: OpGen issued recall letter via email on March 18, 2019. The notification provided reason for recall, health risk, and request to destroy any remaining inventory and return the completed Acknowledgement of Receipt of Notification Letter via OpGen, Inc., Attn: Autumn Collasius Regulatory Affairs,708 Quince Orchard Dr., Suite 205, Gaithersburg, MD 20878; Phone: 1 (301) 869-9683 Fax: 1 (301) 869-9684, e-mail: [email protected]. The response form asks the customer to include how many of the affected slides they currently have in stock and how many they have already used. Questions or requests for further information, please contact OpGen Technical Support: US (Toll-Free): 1-866-376-0009 FAX: 1-301-869-9684 E-mail: [email protected]
Quantity in commerce: 80 slides
Distribution: US Distribution to states of: CT, MI and VA.
Product codes and lots: Lot Number FN80107

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1328-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1328-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-14

Product code LJG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)