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Recall Observatory FDA recall evidence

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

March 18, 2019

Class II

Product summary

Firm
Roche Diagnostics Corporation
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

    reason.no_named_rule · v1.0.0

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