Agency classClass IIIOur severity:Moderate FDA (Devices)·Z-1928-2014·Announced 2014-07-02

Alere Triage BNP Calibrators Recalled Due to Mislabeling

Alere San Diego is recalling BNP calibrators because a Level 5 bottle contains Level 4 material, causing calibration failures.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 III, which is defined as unlikely to cause adverse health consequences. The hazard is a labeling error leading to calibration failure, fitting the criteria for minor labeling errors.

Plain-English summary

Alere San Diego, Inc. is recalling Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202. The recall involves 3,121 kits from Lot #328163.

The recall is being conducted because the bottle labeled as Calibrator Level 5 actually contains Calibrator Level 4. This mislabeling results in a calibration failure when attempting to calibrate using a calibrator kit that contains the affected Level 5 Calibrator.

The affected products were distributed worldwide, including in the United States, Australia, Canada, China, the EU, Mexico, Russia, Singapore, South Africa, South Korea, Taiwan, and the United Arab Emirates. Users should stop using the affected calibrators and contact the manufacturer for instructions.

The recalled product

Product: Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202 The Alere Triage BNP test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type…
Manufacturer: Alere San Diego, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: mis-labeling
calibration-failure
Affected units: 3,121

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)

Lot #328163

Distribution

Distributed nationwide across the United States.

Same manufacturer · Alere San Diego, Inc.

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