FDA Enforcement Class II Terminated

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

Recall: Z-1124-2019 · Reported April 17, 2019

Enforcement

Recall Number: Z-1124-2019
Event ID: 81814
Classification: Class II
Status: Terminated
Product Type: Devices
Firm: Roche Diagnostics Corporation
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: April 17, 2019
Initiation Date: December 14, 2018
Classification Date: April 10, 2019
Termination Date: September 4, 2020
Address: 9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

Description

Reason

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

Code Info

All

Distribution

US Nationwide distribution.

Quantity

656 units