Z-2269-2016Class III

Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes an extract of bovine...

Name: Z-2269-2016 Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes an extract of bovine...
Creator: Alere San Diego, Inc.
Published: 2016-06-22
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2016-06-22 / Terminated / root cause: labeling and UDI

FDA source

Alere San Diego, Inc. began a recall of Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively... on 2016-06-22. FDA classified it as Class III and gives the reason as "The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2269-2016
Classification: Class III
Status: Terminated
Initiated: 2016-06-22
Posted: 2016-07-22
Terminated: 2018-01-29
Recalling firm: Alere San Diego, Inc.
Product: Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 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.
Product code: KTN System, Test, Infectious Mononucleosis
Reason for recall: The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Root cause tag: labeling and UDI
FDA root cause: Unknown/Undetermined by firm
Action: A Medical Device Correction letter dated 6/22/16 will be sent to all customers to inform them that Alere is recalling the MONO Rapid Test products because the Positive Control Information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect. Customers are informed that the labeling states the Positive Control contains the following: Diluted human plasma containing IM heterophile antibodies, 0.09% sodium azide. The Positive Control contains the following: Goat anti-mono antibody, 0.09% sodium azide. Customers are instructed to complete and fax or email the enclosed verification form within 10 days. Customers with questions are instructed to contact Alere San Diego at (844) 804-4945 or email at [email protected].
Distribution: US
Product codes and lots: all lots are affected

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2269-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2265-2016	Class III	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-22
Z-2266-2016	Class III	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-22
Z-2267-2016	Class III	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-22
Z-2268-2016	Class III	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-22
Z-2269-2016	Class III	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-22
Z-2270-2016	Class III	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-22
Z-2271-2016	Class III	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-22

Product code KTN

K042272Class IIAcon Mononucleosis Rapid Test Strip (Whole Blood/serum/plasma)ACON Laboratories, Inc. / cleared 2005-02-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)