Recall Z-0679-2020 ยท LPS Urinary Homocystine (Nonquantitative) Test System
Roche Diagnostics Operations, Inc.
Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems Catalog Number: 06542921190 - - Product Usage: The assay can assist in the diagnosis of patients suspected of having hyperhomocysteinemia or homocystinuria.
| Date | Oct 4, 2019 |
| Status | Terminated |
| Reason | Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules |
| Root cause | Device Design |
| Action | The Urgent Medical Device Correction (UMDC) was sent via Roche issued Urgent Medical Device notification via FedEx (signature required) to the consignee list on 10/04/2019. The letter states issue, health risk nd action to take: Discontinue use and discard the remaining affected product in inventory according to local waste guidelines. Because a replacement lot is currently not available, Roche will issue credit for Homocysteine cobas c packs, lot number 422313, remaining in your inventory. If customers have another validated system (i.e. cobas c501/502) in their lab and wish to set up the |
| Quantity | 82 units (US) |
| Distribution | US Nationwide distribution in the states of NJ, HI, IA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113793 | HOMOCYSTEINE TEST Roche, Jun 5, 2012 |