Skip to content

Roche Diagnostics cobas Integra Albumin Gen.2 recallZ-0152-2020 · Roche Diagnostics Operations, Inc. · initiated Sep 11, 2019

Class III Terminated All recalls posted in October 2019

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Roche Diagnostics Operations, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Due to low Quality Control recovery and invalid Calibration.

FDA root cause category: Under Investigation by firm

What the company is doing

1. Discontinue use and discard the remaining affected product in your inventory according to your local waste guidelines. 2. Complete and fax or email the form even if you are not requesting product replacement. Please contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC. An Urgent Medical Device Correction letter dated 12/18/19 was sent to customers regarding the expansion of the recall to include an additional lot of Albumin Gen.2 Reagent. Actions Required " Discontinue use and discard the remaining affected product in your inventory according to your local waste guidelines. " Complete the attached fax form (TP-00848) and fax or email it according to the instructions on the form even if you are not requesting product replacement. " File this UMDC for future reference. Questions Please contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.

Recall details

Recall number
Z-0152-2020
Recall class
Class III
Status
Terminated
Initiated by the company
Sep 11, 2019
Posted by the FDA
Oct 16, 2019
Recalling firm
Roche Diagnostics Operations, Inc.
Quantity
7,032 units (Expanded on 12/20/19 to include 29,696 additional units)
Product code
CIX
FDA submissions
K033009
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.

Product description

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.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

4 devices cleared under K033009 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 83806).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page