Alere San Diego, Inc. recalls Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are quali…

Recall date

October 12, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0588-2017

FDA classification

Class II

Brand / firm

Alere San Diego, Inc.

Sold / distributed

US Nationwide Distribution

Why it was recalled

Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Value Card.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are quality control materials that are used to assist the laboratory in monitoring test performance throughout the measurable range. They are not calibrators and are not used to calibrate the Triage tests. The results of quality control testing do not impact direct patient care and should not influence clinical decision making process the physician uses to make clinical diagnosis for the patient. Indications for Use: The Alere Triage Total 5 Controls are assayed materials to be used with the Alere Triage Cardiac Panel, Alere Triage CardioProfiler Panel, Alere Triage Profiler SOB Panel, Alere Triage BNP Test, Alere Triage D-Dimer Test, and Alere Triage Meters to assist the laboratory in monitoring test performance.