Alere Triage Total 5 Control Level 1 Recalled for Incorrect Ranges
Alere San Diego, Inc. is recalling 513 kits of Alere Triage Total 5 Control Level 1 because the product was encoded with incorrect ranges that do not match the Expected Value Card.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly states that the results of quality control testing do not impact direct patient care and should not influence clinical decision-making, indicating a low-risk contamination or labeling issue without reported illness.
Plain-English summary
Alere San Diego, Inc. is recalling 513 kits of Alere Triage Total 5 Control Level 1, Model No. 88753, with code C3233A. The product was distributed nationwide in the United States.
The recall was initiated because the product was encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Value Card. The Triage Total Controls 5 are quality control materials used to assist laboratories 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 the clinical decision-making process used by physicians to make clinical diagnoses for patients.
The Alere Triage Total 5 Controls are assayed materials intended for use 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. Users should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- 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…
- Manufacturer
- Alere San Diego, Inc.
- Hazard
- Affected units
- 513
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- C3233A
Distribution
Distributed nationwide across the United States.
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