Roche Cobas c Bilirubin Total Gen.3 Recalled for Quality Control Issues
Roche Diagnostics is recalling 2,304 units of the Cobas c Bilirubin Total Gen.3 in vitro test due to low quality control recovery and invalid calibration.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 2,304 units of the Cobas c Bilirubin Total Gen.3 in vitro test, catalog number 05795419190. The product is used for the quantitative determination of total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems. The recall is limited to Lot # 36133801.
The recall was initiated due to low Quality Control recovery and invalid Calibration. The affected units were distributed nationwide in the United States, including the states of AL, AZ, CA, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MO, NE, NH, NJ, NY, OH, OK, PA, PR, RI, SC, TN, TX, UT, VA, and WI. An update to the distribution list as of December 20, 2019, included the state of CO.
The FDA has classified this recall as Class III. This classification indicates that the use of or exposure to the product is not likely to cause adverse health consequences. Users of the affected product should contact Roche Diagnostics Operations, Inc. for further instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 2,304
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 36133801
Distribution
Part of a larger recall action
This product is one of 2 recalled by Roche Diagnostics Operations, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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