CS011 GNR PNA FISH Control Slide — Class II medical device recall Z-1328-2019
Terminated recall by Opgen Inc, reported 2019-05-22, distributed in CT, MI, VA. May show diminished performance prior to its established expiration date resulting in an invalid control resul
| Recall number | Z-1328-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Opgen Inc, Gaithersburg, MD, United States |
| Recall initiated | 2019-03-18 |
| Classified | 2019-05-14 |
| Reported by FDA | 2019-05-22 |
| Terminated | 2019-08-05 |
| Distributed | CT, MI, VA |
| Quantity | 80 slides |
| Lot numbers | FN80107 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1328-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.