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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83806

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

Open FDA event record

Event summary

Timeline bucket
September 11, 2019
Product types
Device
Classifications
Class III
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

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

Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi cobas c systems.

Z-0152-2020
Recall number
Z-0152-2020
Initiated
September 11, 2019
Classification
Class III
Status
Terminated
Quantity
7,032 units (Expanded on 12/20/19 to include 29,696 additional units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to low Quality Control recovery and invalid Calibration.

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

Due to low Quality Control recovery and invalid Calibration.

Code information

Lot # 33962301. Expanded on 12/20/19 to include lot 37437301

Distribution pattern

US Nationwide distribution including the states of AL, AZ, CA, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MO, NE, NH, NJ, NY, OH, OK, PA, PR, RI, SC, TN, TX, UT, VA and WI. Updated as of 12/20/19 to include the following additional US states: CO.

device · product 2 of 2

Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.

Z-0153-2020
Recall number
Z-0153-2020
Initiated
September 11, 2019
Classification
Class III
Status
Terminated
Quantity
2,304 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to low Quality Control recovery and invalid Calibration.

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

Due to low Quality Control recovery and invalid Calibration.

Code information

Lot # 36133801

Distribution pattern

US Nationwide distribution including the states of AL, AZ, CA, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MO, NE, NH, NJ, NY, OH, OK, PA, PR, RI, SC, TN, TX, UT, VA and WI. Updated as of 12/20/19 to include the following additional US states: CO.