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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Roche Diagnostics Operations, Inc.
Lot Codes / Batch Numbers
Lot Number: 422313 Exp Date: 07/31/2020
Products Sold
Lot Number: 422313 Exp Date: 07/31/2020
Roche Diagnostics Operations, Inc. is recalling Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human due to Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026