Z-2291-2020Class II

4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog...

Name: Z-2291-2020 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog...
Creator: Biocare Medical, LLC
Published: 2019-10-10
License: https://open.fda.gov/license/

Biocare Medical LLC / initiated 2019-10-10 / Terminated

FDA source

Biocare Medical, LLC began a recall of 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H on 2019-10-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2291-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-10
Posted: 2020-06-05
Terminated: 2020-12-02
Recalling firm: Biocare Medical LLC
Product: 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
Product code: NJT Immunohistochemistry Reagents And Kits
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 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 in commerce: 8
Distribution: US: TX, MA, TN, MO, IN
Product codes and lots: Lot Number: 041619-4, Expiration Date: 2020/10

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2291-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2291-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-05

Product code NJT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)