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
Product summary
- 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
Due to low Quality Control recovery and invalid Calibration.