Roche Diagnostics Corporation: Medical Device Recall in 2019 - (Recall #: Z-1194-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 18, 2019

Date Posted: April 24, 2019

Recall Number: Z-1194-2019

Event ID: 82388

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.

Status: Terminated

Product Quantity: 774

Code Information:

Catalog Number 05975573190 Lot Number 35651401

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated