Z-1148-2013Class III

IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test...

Name: Z-1148-2013 IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test...
Creator: Alere San Diego, Inc.
Published: 2013-02-26
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2013-02-26 / Terminated / root cause: manufacturing process

FDA source

Alere San Diego, Inc. began a recall of IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chromatographic immunoassay... on 2013-02-26. FDA classified it as Class III and gives the reason as "Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1148-2013
Classification: Class III
Status: Terminated
Initiated: 2013-02-26
Posted: 2013-04-18
Terminated: 2013-08-29
Recalling firm: Alere San Diego, Inc.
Product: IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood to aid in the diagnosis of infectious Mononucleosis.
Product code: KTN System, Test, Infectious Mononucleosis
Reason for recall: Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Alere sent an Urgent Medical Device Recall letter dated February 26, 2013, to all affected customers. The letter informs the customers of the problems identified and the actions to be taken. Customers with unused product remaining are instructed to immediately discard it. Investigations of customer complaints indicate that the positive control included with this lot may produce false negative results. Customers are instructed to return the attached Verification form. Customers that have consumed all product are instructed to indicate zero under "Quantity Discarded" and complete and fax back the form. Replacement product will be provided for any unused portion of the affected lot based on completion and return of the attached Verification Form. Customers with any questions are instructed to contact Alere Technical Services at (866) 216-0094 or by email at [email protected]. For questions regarding this recall call 858-805-2000, ext 3015.
Quantity in commerce: 78 kits
Distribution: Nationwide Distribution including TN, WA, UT, KS, KY, MN, GA, MA, PA, NY, VT, and the Dist. of Columbia
Product codes and lots: The affected control lot number is 11030386. Lot/Unit Codes: MON1040008 & MON1040016.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1148-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1148-2013	Class III	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-18

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)