Roche Bilirubin Total Gen.3 Recalled for Potential Medical Risk
Roche Diagnostics is recalling Bilirubin Total Gen.3 assays due to new endogenous interference claims that may pose a potential medical risk.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The source text explicitly states the hazard 'may have potential medical risk' but does not report any specific injuries, illnesses, or fatalities. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
Roche Diagnostics Corporation is recalling 5,292 analytical units of Bilirubin Total Gen.3 assays. The affected catalog numbers are 05795397190, 05795419190, 05795320160, 05795338160, 05795346160, and 05795648190. These in vitro tests are used for the quantitative determination of total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.
The recall was initiated because new endogenous interference claims have been established for these assays. The source text notes that these claims may have potential medical risk. The issue affects assays used on the cobas c 311 analyzer, the cobas c 501, 502, 701, and 702 analyzers, and Modular Analytics P/D modules. An update indicates that Cobas c111 and COBAS INTEGRA 400 plus analyzers are also impacted for BILT3 and LACT2 assays.
The product was distributed nationwide in the United States. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice.
The recalled product
- Product
- Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 ***added as of 5/10/19***05795397190, 05795648190 Product Usage: In vitro test for the quantitative determination of total bilirubin in serum and plasma of adults and neonates…
- Manufacturer
- Roche Diagnostics Corporation
- Affected units
- 5,292
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)
- n/a
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Roche Diagnostics Corporation 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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