Roche Molecular Systems, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2216-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

cobas¿ Liat¿ Analyzer

Product Classification:

Class II

Date Initiated: May 9, 2016

Date Posted: July 27, 2016

Recall Number: Z-2216-2016

Event ID: 74094

Reason for Recall:

Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results.

Status: Terminated

Product Quantity: 2

Code Information:

US-IVD: M1-E-00383 & M1-E-00434

Distribution Pattern:

Distributed in NC and WA.

Voluntary or Mandated:

Voluntary: Firm initiated