Roche Diagnostics Corporation: Medical Device Recall in 2018 - (Recall #: Z-1519-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test

Product Classification:

Class II

Date Initiated: January 2, 2018

Date Posted: May 2, 2018

Recall Number: Z-1519-2018

Event ID: 79526

Reason for Recall:

The previous version of method sheets for the Acetaminophen assay on the COBAS INTEGRA 400 plus/800/800 CTS analyzers and the MODULAR ANALYTICS P module are missing the following statement in the Limitations-interference section: "In very rare cases, gammopathy, in particular type IgM (Waldenstr¿m s macroglobulinemia), may cause unreliable results."

Status: Terminated

Product Quantity: 35,111

Code Information:

Lot codes: 11021500 7/31/2016 12361201 5/31/2017 11031700 9/30/2018 15247301 8/31/2017 11071400 1/31/2016 18036001 11/30/2017 11071600 8/10/2016 19329601 1/31/2018 11101500 1/21/2016 20511301 5/31/2018 11111600 4/30/2018 24076801 8/31/2018 60482201 2/29/2016 60852601 5/31/2016 61385701 9/30/2016 62032101 1/31/2017

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated