Roche Diagnostics Corporation: Medical Device Recall in 2019 - (Recall #: Z-1124-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: December 14, 2018

Date Posted: April 17, 2019

Recall Number: Z-1124-2019

Event ID: 81814

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

Status: Terminated

Product Quantity: 656 units

Code Information:

All

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated