Exact FDA event identifier

Event 83525

3 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: July 18, 2019
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Roche Diagnostics Operations, 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

3 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 3

cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001

Z-2476-2019

Recall number: Z-2476-2019
Initiated: July 18, 2019
Classification: Class II
Status: Terminated
Recalling firm: Roche Diagnostics Operations, Inc.
Quantity: 1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Quality issue with high pressure solenoid valves may cause inaccurate 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

Quality issue with high pressure solenoid valves may cause inaccurate results.

Code information

Serial # : 31A1-01

Distribution pattern

State NY MT HI IN MD TX OH KS KY CA FL OR LA MO AK

device · product 2 of 3

Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245001

Z-2477-2019

Recall number: Z-2477-2019
Initiated: July 18, 2019
Classification: Class II
Status: Terminated
Recalling firm: Roche Diagnostics Operations, Inc.
Quantity: 19 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Quality issue with high pressure solenoid valves

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

Quality issue with high pressure solenoid valves

Code information

cobas c 701 module Serial # : 19P2-01, 1390-03, 1139-04, 1139-05, 1139-06. cobas c 702 module serial # : 1126-03, 1237-10, 14C2-04 cobas¿ 8000 ISE module serial # : 1943-01, 1943-02, 1943-03, 1943-04, 1943-05, 1943-06, 1943-07, 1943-08, 1943-09, 1943-10, 15B3-05.

Distribution pattern

State NY MT HI IN MD TX OH KS KY CA FL OR LA MO AK

device · product 3 of 3

cobas c513 Analyzer

Z-2478-2019

Recall number: Z-2478-2019
Initiated: July 18, 2019
Classification: Class II
Status: Terminated
Recalling firm: Roche Diagnostics Operations, Inc.
Quantity: 2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Quality issue with high pressure solenoid valves

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

Quality issue with high pressure solenoid valves

Code information

Serial # :1731-08, 1722-03

Distribution pattern

State NY MT HI IN MD TX OH KS KY CA FL OR LA MO AK