4plus Streptavidin HRP Label (Biocare Medical) – no staining detected (2019)
Product staining failure can potentially cause invalid medical test results.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
Brand
Biocare Medical, LLC
Lot Codes / Batch Numbers
Lot Number: 041619-4, Expiration Date: 2020/10
Products Sold
Lot Number: 041619-4, Expiration Date: 2020/10
Biocare Medical, LLC is recalling 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, due to Firm has identified product has no staining. If used, may result in invalid test results when used with controls in the clinical setting. Positive con. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, MA, MO, TN, TX
Page updated: Jan 10, 2026