4plus Streptavidin HRP Label — Class II medical device recall Z-2291-2020
Terminated recall by Biocare Medical, LLC, reported 2020-06-17, distributed in IN, MA, MO, TN, TX. Firm has identified product has no staining. If used, may result in invalid test results when used with contro
| Recall number | Z-2291-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biocare Medical, LLC, Pacheco, CA, United States |
| Recall initiated | 2019-10-10 |
| Classified | 2020-06-05 |
| Reported by FDA | 2020-06-17 |
| Terminated | 2020-12-02 |
| Distributed | IN, MA, MO, TN, TX |
| Quantity | 8 |
| Lot numbers | 041619-4, 2020/10 |
| Model numbers | HP604H |
Product
4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
Reason for recall
Firm has identified product has no staining. If used, may result in invalid test results when used with controls in the clinical setting. Positive control would observe no staining. The clinical impact may result in the consumption of patient tissue sample and a delay in diagnosis.
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-2291-2020. 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.