Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Recalled by Roche Diagnostics Operations, Inc. Due to Due to low Quality Control recovery and invalid...
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 Operations, Inc. directly.
Affected Products
Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi cobas c systems.
Quantity: 7,032 units (Expanded on 12/20/19 to include 29,696 additional units)
Why Was This Recalled?
Due to low Quality Control recovery and invalid Calibration.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Roche Diagnostics Operations, Inc.
Roche Diagnostics Operations, Inc. has 127 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report