—#177008

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.

FDA product code: LPS — Urinary Homocystine (Nonquantitative) Test System
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K113793
Affected lot / code info: Lot Number: 422313 Exp Date: 07/31/2020

Why it was recalled

Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: US Nationwide distribution in the states of NJ, HI, IA.

Timeline

Recall initiated: 2019-10-04
Terminated: 2020-10-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #177008. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.