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Recall Observatory FDA recall evidence

Device product

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

September 11, 2019

Class III

Product summary

Firm
Roche Diagnostics Operations, Inc.
Event
Event 83806
Status
Terminated
Classification
Class III
Quantity
7,032 units (Expanded on 12/20/19 to include 29,696 additional units)
Official record key
device-enforcement:Z-0152-2020

Official wording

Reason: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to low Quality Control recovery and invalid Calibration.