Class 2 Device Recall Horseradish peroxidase (HRP)antibody conjugate system

• Date Initiated by Firm: October 10, 2019
• Create Date: June 05, 2020
• Recall Status: Terminated on December 02, 2020
• Recall Number: Z-2291-2020
• Recall Event ID: 85359
• Product Classification: Immunohistochemistry reagents and kits - Product Code NJT
• Product: 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
• Code Information: Lot Number: 041619-4, Expiration Date: 2020/10
• Recalling Firm/ Manufacturer: Biocare Medical, LLC; 60 Berry Dr; Pacheco CA 94553-5601
• For Additional Information Contact: 925-603-8002
• Manufacturer 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.
• FDA Determined 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 in Commerce: 8
• Distribution: US: TX, MA, TN, MO, IN
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.