Homocysteine test system - Homocysteine Reagent recallZ-1622-2015 · Roche Diagnostics Operations, Inc. · initiated Mar 23, 2015
Class II Terminated All recalls posted in May 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Roche Diagnostics Operations, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1622-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 23, 2015
- Posted by the FDA
- May 15, 2015
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 2558 units
- Product code
- LPS
- FDA submissions
- K113793
- Distribution
- 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.
Product description
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.
Code information (models, lots, serial numbers)
05385415190, Homocysteine 100Tests, cobas c, COBAS INTEGRA Lot number 69781101
Other devices under the same FDA submission
2 devices cleared under K113793 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Homocysteine Enzymatic Assay 6542921190Roche Diagnostics GmbH · URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM1 recall0 reports
- Homocysteine Enzymatic Assay 08057826190Roche Diagnostics GmbH · URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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