Recall Z-0588-2017— Alere San Diego, Inc.

Name: FDA recall Z-0588-2017
Creator: U.S. Food and Drug Administration
Published: 2016-10-12

Class II · Terminated

Class II FDA medical device recall by Alere San Diego, Inc., initiated 2016-10-12, terminated 2017-07-24. It names one FDA 510(k) clearance: K072892. Product: 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: Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Value Card..

Recalling firm: Alere San Diego, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-10-12
Terminated: 2017-07-24
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K072892 — TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5Biosite Incorporated·cleared 2007-12-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.