CLASS III Device recall · Reported 3 Aug 2016 · FDA Enforcement Report

Signify Mono (Whole Blood, Serum, Plasma) recalled by Alere San Diego

Alere San Diego is recalling Signify Mono (Whole Blood, Serum, Plasma). The recall was initiated on 22 Jun 2016 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesall lots are affected

Quantity recalledN/A

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-2271-2016
FDA event ID: 74505
Recalling firm: Alere San Diego, San Diego, CA
Classification: Class III
Status: Terminated
Recall initiated: 22 Jun 2016
FDA classified: 22 Jul 2016
Reported: 3 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

22 Jun 2016	Recall initiated by company
22 Jul 2016	Classified by FDA	+30 days
3 Aug 2016	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.

Where it was distributed

Questions about this recall

Why was it recalled?

The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.

Which lots are affected?

all lots are affected

Where was it sold?

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 74505

This product is part of a recall event; the main page for the event is Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma) recalled.

Reported	Class	Recall	Company	Reason	Where
3 Aug 2016	CLASS III	Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma) recalled	Alere San Diego	Packaging Defects	CA
3 Aug 2016	CLASS III	Henry Schein One Step + Mono Rapid Test Device recalled	Alere San Diego	Packaging Defects	CA
3 Aug 2016	CLASS III	Cardinal Health Mono Rapid Test recalled by Alere San Diego	Alere San Diego	Packaging Defects	CA
3 Aug 2016	CLASS III	Proadvantage Mono Rapid Test Cassette recalled by Alere San Diego	Alere San Diego	Packaging Defects	CA
3 Aug 2016	CLASS III	Stanbio Rely Mono Rapid Test recalled by Alere San Diego	Alere San Diego	Packaging Defects	CA
3 Aug 2016	CLASS III	Clearview MONO (Whole Blood, Serum, Plasma) recalled by Alere San Diego	Alere San Diego	Packaging Defects	CA

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