Device product
Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems.
Z-1194-2019
Product summary
- Event
- Event 82388
- Status
- Terminated
- Classification
- Class II
- Quantity
- 774
- Official record key
device-enforcement:Z-1194-2019
Official wording
Reason: The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values.
Code information: Catalog Number 05975573190 Lot Number 35651401
Distribution pattern: US Nationwide distribution in the states of: GA, IL, KY, MI, and TX.
Derived failure modes
-
Unknown
The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values.