Z-0152-2020 Class III Terminated
FDA device recall Z-0152-2020 was initiated by Roche Diagnostics Operations, Inc. on September 11, 2019 and is designated Class III. Reason for recall: Due to low Quality Control recovery and invalid Calibration. The recall status is terminated (terminated June 11, 2024). Affected quantity: 7,032 units (Expanded on 12/20/19 to include 29,696 additional units).
Recall Details
- Product Type
- Devices
- Report Date
- October 23, 2019
- Initiation Date
- September 11, 2019
- Termination Date
- June 11, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,032 units (Expanded on 12/20/19 to include 29,696 additional units)
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.
Reason for Recall
Due to low Quality Control recovery and invalid Calibration.
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.
Code Information
Lot # 33962301. Expanded on 12/20/19 to include lot 37437301