CLASS II Device recall · Reported 23 Nov 2016 · FDA Enforcement Report
The Triage Total Controls 5 are quality control materials recalled
Alere San Diego is recalling The Triage Total Controls 5 are quality control materials that are used to assist the, distributed nationwide in the US. The recall was initiated on 12 Oct 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0588-2017
- FDA event ID
- 75443
- Recalling firm
- Alere San Diego, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Oct 2016
- FDA classified
- 16 Nov 2016
- Reported
- 23 Nov 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Patient Monitors
Timeline
| 12 Oct 2016 | Recall initiated by company | |
| 16 Nov 2016 | Classified by FDA | +35 days |
| 23 Nov 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Value Card.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is The Triage Total Controls 5 are quality control materials that are used to assist the recalled?
Yes. Alere San Diego recalled The Triage Total Controls 5 are quality control materials that are used to assist the on 12 Oct 2016. The recall is Class II and its status is Terminated. Recall number Z-0588-2017.
Why was it recalled?
Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Value Card.
Which lots are affected?
C3233A
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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