Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86879

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

Open FDA event record

Event summary

Timeline bucket
November 19, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Roche Molecular Systems, 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

The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic acids. The analyzer is intended to be used as an in-vitro diagnostic or screening system providing real time PCR amplification and detection for human samples within the system. The cobas x 480 instrument and cobas z 480 analyzer are to be used by laboratory professionals trained in laboratory techniques and by instruction on the use of the system and analyzer. In the U.S. the cobas z 480 analyzer is used for automated amplification and detection purposes for the following assays: cobas¿ 4800 BRAF V600 Mutation Test cobas¿ Cdiff Test for use on the cobas¿ 4800 System cobas¿ CT/NG v2.0 Test cobas¿ EGFR Mutation Test v2 cobas¿ Factor II and Factor V Test cobas¿ 4800 HPV Test cobas¿ HSV 1 and 2 Test for use on the cobas¿ 4800 System cobas¿ KRAS Mutation Test cobas¿ MRSA/SA Test for use on the cobas¿ 4800 System

Z-0846-2021
Recall number
Z-0846-2021
Initiated
November 19, 2020
Classification
Class II
Status
Terminated
Quantity
597 units US; 3411 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Dirty Lens May Cause Invalid or False Positive Results

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Dirty Lens May Cause Invalid or False Positive Results

Code information

All units UDI: 04015630929016

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Canada, Germany, Italy, Spain, United Kingdom, France, Austria, Turkey, Belgium, Poland, Portugal, Greece, Netherlands, Switzerland, Czech Republic, Romania, Sweden, Norway, Denmark, Hungary, Ireland, Slovakia, Croatia, Bulgaria, Finland, Lithuania, Bosnia-Herz, Slovenia, Iceland, Estonia, Australia, Cambodia, China, Hong Kong, India, Indonesia, Japan, Malaysia, Mongolia, Myanmar, New Zealand, Pakistan, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam, Argentina, Aruba, Bahamas, Barbados, Belize, Brazil, Chile, Colombia, Costa Rica, Cuba, Dominican Rep., Ecuador, El Salvador, Guatemala, Honduras, Jamaica, Mexico, Panama, Paraguay, Peru, Uruguay, Venezuela, Iran, Israel, Kazakhstan, Kosovo, Lebanon, Macedonia, Oman, Russia, Saudi Arabia, South Africa, Sudan, Ukraine, UAE, Serbia, Montenegro, Algeria, Azerbaijan, Botswana, Burkina-Faso, Ethiopia, French Guayana, Gabon, Ghana, Guadeloupe, Lesotho, Martinique, Morocco, Nicaragua, Senegal, Sri Lanka, Tanzania, Tunisia, Uzbekistan, Zambia.

Field note

Send feedback

We'll only use this to respond to your feedback.