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.
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.
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.
The product fails to stain as it should, causing positive controls to show no staining. This leads to invalid test results, potentially causing doctors to consume patient tissue samples and delay diagnosis.
Lab technicians and healthcare providers using the 4plus Streptavidin HRP Label for clinical testing. Patients whose tests could be delayed or misdiagnosed due to this component.
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.
Look for catalog number HP604H and lot number 041619-4 on the product label.
The product has no staining, which can cause invalid test results and potentially delay diagnosis.
The recall record does not specify a remedy, so check the product label for the catalog number and lot number to confirm if it's affected.
The recall record states the risk may lead to delayed diagnosis, but does not mention injury or harm to users.
We’ve drafted a message you can send Biocare Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2291-2020 — Biocare Medical Biocare Medical Hello, I own a Biocare Medical that is covered by recall Z-2291-2020 from Biocare Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
