Sentinel CH SpA: Medical Device Recall in 2015 - (Recall #: Z-0164-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.

Product Classification:

Class II

Date Initiated: September 22, 2015

Date Posted: November 4, 2015

Recall Number: Z-0164-2016

Event ID: 72311

Reason for Recall:

Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.

Status: Terminated

Product Quantity: 765 kits

Code Information:

Lot 50083Y600, expiration date 31 Jul 2016.

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated