Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Albumin BCP Product Usage: ALBP is an in vitro test Recalled by Roche Diagnostics Corporation Due to The reagent lot is exhibiting calibration failures, QC...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Roche Diagnostics Corporation directly.
Affected Products
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.
Quantity: 774
Why Was This Recalled?
The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Roche Diagnostics Corporation
Roche Diagnostics Corporation has 39 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report