Recall Z-0152-2020 ยท CIX Bromcresol Green Dye-Binding, Albumin
Roche Diagnostics Operations, Inc.
Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma 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 | 7,032 units (Expanded on 12/20/19 to include 29,696 additional 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
| K033009 | ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2 Roche Diagnostics Corp., Oct 16, 2003 |