Recall Z-0153-2020 ยท CIG Diazo Colorimetry, Bilirubin
Roche Diagnostics Operations, Inc.
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.
| Date | Oct 16, 2019 (initiated Sep 11, 2019) |
| Status | Terminated |
| Reason | Due to low Quality Control recovery and invalid Calibration. |
| Root cause | Under Investigation by firm |
| Action | 1. Discontinue use and discard the remaining affected product in your inventory according to your local waste guidelines. 2. Complete and fax or email the form even if you are not requesting product replacement. Please contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC. An Urgent Medical Device Correction letter dated 12/18/19 was sent to customers regarding the expansion of the recall to include an additional lot of Albumin Gen.2 Reagent. Actions Required " Disco |
| Quantity | 2,304 units |
| Distribution | US Nationwide distribution 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. Updated as of 12/20/19 to include the following additional US states: CO. |
| 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 |