Recall Z-1028-2013 ยท OOI Real Time Nucleic Acid Amplification System
Roche Diagnostics Operations, Inc.
Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the cobas CT/NG 4800 System, for in vitro diagnostics.
| Date | Apr 1, 2013 (initiated Mar 1, 2013) |
| Status | Terminated |
| Reason | Certain lots of Reagent reservoirs, may not have a separation in the lower part of the reservoir. As a consequence, pipetting errors can occur due to uneven distribution of reagent. These pipetting errors may lead to delayed results and wasted reagent. |
| Root cause | Process control |
| Action | Roche sent a Urgent Medical Device Correction letter via UPS to all affected customers ( receipt required) The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed to visually inspect affected product for the molding defect and to verify equal distribution of reagent in both chambers of the reservoir after adding reagent. All customers are requested to fill out the FAX Back form to schedule shipment of defective part. Non-responding accounts will be monitored on an ongoing basis and follow-up attempts will be made. Ques |
| Quantity | 189 units |
| Distribution | Nationwide Distribution including Puerto Rico and the states of MO, NE, CO, MT, NJ, FL, WA, TX, GA, NY, KS, NH, VA, HI, PA, MI, IA, CA, NC, AZ, UT, LA, IL, TN, ME, MN, KY, CT, OR, NV, AL and NM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110923 | COBAS 4800 CT / NG TEST Roche Molecular Systems, Inc., Jan 24, 2012 |