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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76628

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

Open FDA event record

Event summary

Timeline bucket
March 01, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Roche Diagnostics Corporation

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

2 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 2

Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx

Z-1763-2017
Recall number
Z-1763-2017
Initiated
March 01, 2017
Classification
Class II
Status
Terminated
Quantity
45 Units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software version 02-xx, only when rack buffering is activated and the rack buffer is completely full. This issue can

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

"Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Cobas 8100 bi-directional reformatter (BRF) and uni-directional reformatter (URF) modules with software version 02-xx, only when rack buffering is activated and the rack buffer is completely full. This issue can lead to sample spillage, posing a potential risk to operators / laboratory staff due to exposure to potentially infectious material, cross-contamination of samples in the affected racks and erroneous results due to sample carry-over."

Code information

Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx Catalog Number: 743995400

Distribution pattern

Domestic: MA, IN, AL, OH, MO, NE, LA, CA, IA, NJ, AR, PA, SC, IL, TX, and MI. Foreign: None

device · product 2 of 2

Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx

Z-1764-2017
Recall number
Z-1764-2017
Initiated
March 01, 2017
Classification
Class II
Status
Terminated
Quantity
45

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software version 02-xx, only when rack buffering is activated and the rack buffer is completely full. This issue can

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

Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Cobas 8100 bi-directional reformatter (BRF) and uni-directional reformatter (BRF) modules with software version 02-xx, only when rack buffering is activated and the rack buffer is completely full. This issue can lead to sample spillage, posing a potential risk to operators / laboratory staff due to exposure to potentially infectious material, cross-contamination of samples in the affected racks and erroneous results due to sample carry-over.

Code information

Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx Catalog Number: URF module: 07441657001

Distribution pattern

Domestic: MA, IN, AL, OH, MO, NE, LA, CA, IA, NJ, AR, PA, SC, IL, TX, and MI. Foreign: None