FDA Device recall Z-1328-2019
CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit . In-Vitro Diagnostic The CS01…
- FDA Device
- Class II
- terminated
- Published 2019-05-22
On 2019-05-22 the FDA classified a Class II 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 CS01… by Opgen, citing may show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1328-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-18 |
| Published | 2019-05-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Opgen |
| Distribution | CT, MI, VA |
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
May show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test
Identifiers
| code_info | Lot Number FN80107 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1328-2019%22
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