—#135909

Product

Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA Homocysteine Enzymatic Assay is an in vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems.

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: 05385415190, Homocysteine 100Tests, cobas c, COBAS INTEGRA Lot number 69781101

Why it was recalled

Customers complained about under-recovery of non-Roche controls and discrepant low patient results with certain Homocysteine reagent lots. This negative bias could, in the worst case, lead to inaccurately low Homocysteine results. An elevated level of Homocysteine is considered an important risk factor in the assessment of peripheral vascular disease. Falsely low values could lead to a delay of di

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Roche Diagnostics sent URGENT MEDICAL DEVICE CORRECTION notifications dated 3/23/2015 to affected direct accounts via UPS. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Please 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.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution-including PR and the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, , SC, TN, TX, VA, WA, and WV.

Timeline

Recall initiated: 2015-03-23
Posted by FDA: 2015-05-15
Terminated: 2016-01-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #135909. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.