Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product 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
Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.
Quantity: 2,304 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