IMO-402 Mononucleosis Rapid Test Device — Class III medical device recall Z-1148-2013
Terminated recall by Alere San Diego, Inc., reported 2013-04-24, distributed nationwide. Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the
| Recall number | Z-1148-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alere San Diego, Inc., San Diego, CA, United States |
| Recall initiated | 2013-02-26 |
| Classified | 2013-04-18 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2013-08-29 |
| Distributed | Nationwide (US) |
| Quantity | 78 kits |
| Lot numbers | 11030386 |
| Model numbers | IMO-402/94201 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1148-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.