Recall Z-0679-2020
Roche Diagnostics Operations, Inc. · initiated October 4, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Lot Number: 422313 Exp Date: 07/31/2020
Reason for recall
Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules
FDA-determined cause: Device Design
Action taken
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 Roche Homocysteine assay on one of these modules (different catalog number than that subject to this recall), they will be instructed to contact a Roche Field Specialist for support. " A reimbursement for send out testing to an accredited laboratory will also be provided for those customers without another Roche system available. 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 The UMDC will also be posted to the diagnostics.roche.com website.
Details
- Recall number
- Z-0679-2020
- Initiated
- October 4, 2019
- Terminated
- October 9, 2020
- Product code
- LPS – Urinary Homocystine (Nonquantitative) Test System
- Quantity
- 82 units (US)
- Distribution
- US Nationwide distribution in the states of NJ, HI, IA.
- Recalling firm
- Roche Diagnostics Operations, Inc., Indianapolis, IN