4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
Recall
- Recall Number
- Z-2291-2020
- Event Number
- 85359
- Firm
- Biocare Medical, LLC
- FEI Number
- 3004140393
- Product Code
- NJT
- Status
- Terminated
- Root Cause
- Pending
- Initiated
- October 10, 2019
- Terminated
- December 2, 2020
- Address
- 60 Berry Dr, Pacheco, CA, 94553-5601
Description
4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
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.
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.
US: TX, MA, TN, MO, IN
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