Exact FDA event identifier

Event 82665

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: March 18, 2019
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Opgen Inc

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1328-2019

Recall number: Z-1328-2019
Initiated: March 18, 2019
Classification: Class II
Status: Terminated
Recalling firm: Opgen Inc
Quantity: 80 slides

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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

Code information

Lot Number FN80107

Distribution pattern

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