Recall Z-2291-2020— Biocare Medical, LLC
Class II · Terminated
Class II FDA medical device recall by Biocare Medical, LLC, initiated 2019-10-10, terminated 2020-12-02. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Biocare Medical, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-10-10
- Terminated
- 2020-12-02
- Firm location
- Pacheco, CA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.