FDA Medical Device · Z-0152-2020

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.

Class III · Terminated

Due to low Quality Control recovery and invalid Calibration.

Affected lots / codes — check yours against thisLot # 33962301. Expanded on 12/20/19 to include lot 37437301

Recalling firm: Roche Diagnostics Operations, Inc., Indianapolis, IN
Classification: Class III (unlikely to cause harm)
Status: Terminated
Quantity: 7,032 units (Expanded on 12/20/19 to include 29,696 additional units)
Distribution: 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.
Recall initiated: September 11, 2019
Classified: October 16, 2019
Terminated: June 11, 2024
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0152-2020%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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