FDA Medical Device Recalls (openFDA)
Biocare Medical, LLC: 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
- Recall number
- Z-2291-2020
- Recalling firm
- Biocare Medical, LLC
- Product
- 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
- Status
- Terminated
- Initiated
- 2019-10-10
- Posted
- not on file
- Terminated
- 2020-12-02
- 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.
- Root cause
- Pending
- Action
- On 10/10/2019, the firm notified affected customers via posting and email of "Medical Device Recall Notification" letter. indicating: (1) Please immediately discontinue use and distribution of the identified affected lot number. Ship affected products using the UPS or FedEx account provided to the firm. A product replacement will be sent to the customer at no charge. (2) If you may have further distributed this product, please identify those customers and notify them at once of this product recall. Your notification to your customers should include a copy of this recall notification letter. (3) Please complete and return the enclosed Return Response Form by October 25, 2019 via fax via fax at 1- 925-603-8080 (Attn: Regulatory Affairs). The completed form may also be emailed to the regulatory team. Recalling firm telephone contact: 1-800-799-9499.
- Quantity
- 8
- Distribution
- US: TX, MA, TN, MO, IN
- Lot, serial or model codes
- Lot Number: 041619-4, Expiration Date: 2020/10
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NJT
- Firm FEI
- 3004140393
- Firm city
- Pacheco
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28