Z-0588-2017 Class II Terminated
FDA device recall Z-0588-2017 was initiated by Alere San Diego, Inc. on Oct 12, 2016 and is designated Class II. Reason for recall: Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Value Card. The recall status is terminated (terminated Jul 24, 2017). Affected quantity: 513 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 23, 2016
- Initiation Date
- Oct 12, 2016
- Termination Date
- Jul 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0588-2017
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026