Home / Recalls / Roche Diagnostics Corporation / Z-1124-2019

Z-1124-2019 Class II Terminated

Recalled by Roche Diagnostics Corporation — Indianapolis, IN

Recall Details

Product Type
Devices
Report Date
April 17, 2019
Initiation Date
December 14, 2018
Termination Date
September 4, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
656 units

Product Description

COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2 Catalog Number: 03032566122 b)Tina-quant Albumin Gen.2 Catalog Number 04469658190 c)Creatinine plus ver.2 Catalog Number 03263991190 d) riglycerides Catalog Number :20767107322 - 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

Distribution Pattern

US Nationwide distribution.

Code Information

All

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