Henry Schein One Step + Mono Rapid Test Device — Class III medical device recall Z-2268-2016
Terminated recall by Alere San Diego, Inc., reported 2016-08-03. The Positive Control information referencing human plasma as the antibody material described in the product la
| Recall number | Z-2268-2016 |
|---|---|
| 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 | 2016-06-22 |
| Classified | 2016-07-22 |
| Reported by FDA | 2016-08-03 |
| Terminated | 2018-01-29 |
| Reason classes | labeling |
| Model numbers | 9004070 |
Product
Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 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.
Reason for recall
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
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-2268-2016. 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.