Reported Nov 23, 2016 · Terminated
Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are…
Alere San Diego, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alere San Diego, Inc. · 9975 Summers Ridge Rd · San Diego, CA · 92121-2997
Is this the product you have?
Alere Triage Total 5 Control Level 1Model No. 88753
- Description of the productThe 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 UseThe 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
- Lot codes and dates
- C3233A
- Amount recalled
- 513 kits
Where it was sold
- Nationwide
Why it was recalled
Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Value Card.
This product could cause temporary or reversible health problems — stop using it.
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