Lower risk Medical device recall · FDA · Published October 10, 2019

Biocare Medical 4plus Streptavidin HRP Label Recall: Invalid Test Results Risk

Biocare Medical recalls 4plus Streptavidin HRP Label (HP604H) due to potential invalid test results. This may cause patient tissue consumption and delayed diagnosis. Affected units have specific lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2291-2020Medical device Biocare Medical ›

Lower-risk 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.

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Contact the company

Recalling firmBiocare Medical, LLC60 Berry Dr · Pacheco, CA 94553-5601

✎ GovInfoNow plain-language explainer

Biocare Medical is recalling a specific lab test component because it doesn't stain properly. This could lead to false negative results, meaning doctors might miss critical diagnoses and delay treatment. The issue affects only certain lab products with specific lot numbers. Read more at govinfonow.com/recall/66841-biocare-medical-4plus-streptavidin-hrp-label-recall-invalid-test-results.

Source Summary by GovInfoNow · govinfonow.com/recall/66841-biocare-medical-4plus-streptavidin-hrp-label-recall-invalid-test-results · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2291-2020

Cite this page

“Biocare Medical 4plus Streptavidin HRP Label Recall: Invalid Test Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66841-biocare-medical-4plus-streptavidin-hrp-label-recall-invalid-test-results. Based on FDA recall #Z-2291-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2291-2020%22&limit=1).

The FDA announced on 2019-10-10 that Biocare Medical, LLC voluntarily recalled the 4plus Streptavidin HRP Label due to a lack of staining that may cause invalid test results. The agency issued recall number Z-2291-2020 for the Class II device.

How to tell if you have it

Brand: Biocare Medical
Product: 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component
Catalog Number: HP604H
Lot Number: 041619-4
Expiration Date: 2020/10
Quantity: 8 units
Distribution: TX, MA, TN, MO, IN

The hazard

The product has no staining, which may result in invalid test results when used with controls in the clinical setting. A positive control would observe no staining. The clinical impact may result in the consumption of patient tissue sample and a delay in diagnosis.

Context

GovInfoNow's records show Biocare Medical, LLC has 4 other recalls on record since 2018-03-15. Other recent recalls of similar products include Vivoo Protein Test Recall (2025-11-22), Vivoo pH Test Recall (2025-11-22) and Vivoo Test Strips Recall (2025-11-22).

How to tell if you have this one

Check for the catalog number HP604H and lot number 041619-4 on the product label. The expiration date is 2020/10. This product is used in clinical settings for specific lab tests.

Brand
Biocare Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for catalog number HP604H and lot number 041619-4 on the product label.

Where it went and when

Where it was distributed

Distributed in 5 states.

FDA distribution: “US: TX, MA, TN, MO, IN” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Indiana, Massachusetts, Missouri, Tennessee, Texas.

Recall timeline

FDA terminated this recall 14 months after the firm started it.

Oct 10, 2019Firm started the recall
Jun 5, 2020FDA classified it Class II
Jun 17, 2020Published in FDA’s Enforcement Report
Dec 2, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/66841-biocare-medical-4plus-streptavidin-hrp-label-recall-invalid-test-results">Biocare Medical 4plus Streptavidin HRP Label Recall: Invalid Test Results Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2291-2020 (October 10, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2291-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.