FDA Devices Low Class III Terminated

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.

Reported: October 23, 2019 Initiated: September 11, 2019 #Z-0152-2020

Product Description

Reason for Recall

Due to low Quality Control recovery and invalid Calibration.

Details

Recalling Firm: Roche Diagnostics Operations, Inc.
Units Affected: 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.
Location: Indianapolis, IN

Frequently Asked Questions

What product was recalled? ▼

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.. Recalled by Roche Diagnostics Operations, Inc.. Units affected: 7,032 units (Expanded on 12/20/19 to include 29,696 additional units).

Why was this product recalled? ▼

Due to low Quality Control recovery and invalid Calibration.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on October 23, 2019. Severity: Low. Recall number: Z-0152-2020.