Class II — Biocare Medical, LLC
| Recalling firm | BIOCARE HOLDINGS, LLC |
|---|---|
| Registered facility | BIOCARE MEDICAL, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H |
| Quantity | 8 |
| Distribution | US: TX, MA, TN, MO, IN |
| Initiated | 2019-10-10 |
| Classified | 2020-06-05 |
| Terminated | 2020-12-02 |
| Recall number | Z-2291-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Biocare Medical, LLC (Z-2291-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85359/
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