FDA recall Z-1194-2019

Roche Diagnostics Corporation · Class II · 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.

Reason for recall

The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values.

Distribution

US Nationwide distribution in the states of: GA, IL, KY, MI, and TX.

Key facts

Status
Terminated
Initiation date
2019-03-18
Report date
2019-04-24
Termination date
2020-08-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1194-2019