FDA Device recall Z-1148-2013
IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma)
- FDA Device
- Class III
- terminated
- Published 2013-04-24
On 2013-04-24 the FDA classified a Class III recall of IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma) by Alere San Diego, citing alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1148-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-02-26 |
| Published | 2013-04-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Alere San Diego |
| Distribution | US |
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
Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results.
Identifiers
| code_info | The affected control lot number is 11030386. Lot/Unit Codes: MON1040008 & MON1040016. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1148-2013%22
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