Home / Recalls / Alere San Diego, Inc. / Z-0588-2017

Z-0588-2017 Class II Terminated

Recalled by Alere San Diego, Inc. — San Diego, CA

Recall Details

Product Type
Devices
Report Date
November 23, 2016
Initiation Date
October 12, 2016
Termination Date
July 24, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
513 kits

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.

Reason for Recall

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

Distribution Pattern

US Nationwide Distribution

Code Information

C3233A

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