Z-2291-2020 Class II Terminated
FDA device recall Z-2291-2020 was initiated by Biocare Medical, LLC on October 10, 2019 and is designated Class II. 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 impac… The recall status is terminated (terminated December 2, 2020). Affected quantity: 8.
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2020
- Initiation Date
- October 10, 2019
- Termination Date
- December 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8
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.
Distribution Pattern
US: TX, MA, TN, MO, IN
Code Information
Lot Number: 041619-4, Expiration Date: 2020/10