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.
This recall has been terminated (originally issued October 16, 2019).
- Recall Initiated
- September 11, 2019
- Posted
- October 16, 2019
- Terminated
- June 11, 2024
- Recall Number
- Z-0153-2020
- Quantity
- 2,304 units
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Due to low Quality Control recovery and invalid Calibration.
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.
Lot / Code Info
Lot # 36133801
Root Cause
Under Investigation by firm
Action Taken
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 " Discontinue use and discard the remaining affected product in your inventory according to your local waste guidelines. " Complete the attached fax form (TP-00848) and fax or email it according to the instructions on the form even if you are not requesting product replacement. " File this UMDC for future reference. Questions 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.