Z-1622-2015 Class II Terminated
FDA device recall Z-1622-2015 was initiated by Roche Diagnostics Operations, Inc. on Mar 23, 2015 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Jan 19, 2016). Affected quantity: 2558 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 27, 2015
- Initiation Date
- Mar 23, 2015
- Termination Date
- Jan 19, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2558 units
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.
Reason for Recall
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
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.
Code Information
05385415190, Homocysteine 100Tests, cobas c, COBAS INTEGRA Lot number 69781101
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1622-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026