FDA Device recall Z-2291-2020
4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
- FDA Device
- Class II
- terminated
- Published 2020-06-17
On 2020-06-17 the FDA classified a Class II recall of 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H by Biocare Medical, citing 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 stainin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2291-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-10 |
| Published | 2020-06-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Biocare Medical |
| Distribution | IN, MA, MO, TN, TX |
Product
4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
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.
Identifiers
| code_info | Lot Number: 041619-4, Expiration Date: 2020/10 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2291-2020%22
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