Alere San Diego, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0588-2017)

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:

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.

Product Classification:

Class II

Date Initiated: October 12, 2016

Date Posted: November 23, 2016

Recall Number: Z-0588-2017

Event ID: 75443

Reason for Recall:

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

Status: Terminated

Product Quantity: 513 kits

Code Information:

C3233A

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated