Recall Z-1145-2019 ยท CIG Diazo Colorimetry, Bilirubin
Roche Diagnostics Corporation
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 on Roche/Hitachi cobas c systems.
| Date | Apr 13, 2019 (initiated Dec 17, 2018) |
| Status | Terminated |
| Reason | New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D modules which may have potential medical risk. ***Update: Cobas c111 and COBAS INTEGRA 400 plus analyzers are also impacted for BILT3 and LACT2 assays*** |
| Root cause | Device Design |
| Action | On 12/17/18, the firm distributed an Urgent Medical Device Correction letter to affected consignees. Customers were notified of the interference issues. The Limitations-interference section of the method sheets for the cobas c 311 analyzer and the cobas c 501, 502, 701, and 702 modules are being updated with the following claims: Bilirubin Total Gen.3 assay: Immunoglobulins: No significant interference from immunoglobulins up to a concentration of 28 g/L (187 mol/L) (simulated by human immunogloblulin G). Lactate Gen.2 assay (CSF samples): Ditaurobilirubin: No significant interference from di |
| Quantity | 5292 analytical units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131544 | COBAS C BILIRUBIN TOTAL GEN.3 Roche Diagnostics, Jul 17, 2013 |