cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 ...
FDA Recall #Z-1125-2019 — Class II — December 14, 2018
Product Description
cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Catalog Number: 05401470190; b)Triglycerides Catalog Number: 04657594190 - Product Usage: Tina-quant Apolipoprotein A-1 ver.2 A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis Tina-quant Albumin Gen.2 Immunoturbidimetric assay for the quantitative, in vitro determination of albumin in human urine, serum, plasma, and CSF on Roche/Hitachi cobas c systems
Reason for Recall
COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over
Recalling Firm
Roche Diagnostics Corporation — Indianapolis, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
137 units
Distribution
US Nationwide distribution.
Code Information
All
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated