Biocare Medical Recalls 4plus Streptavidin HRP Label Due to Staining Failure
Biocare Medical is recalling 4plus Streptavidin HRP Label kits because they may fail to stain, potentially causing invalid test results and delayed diagnoses.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (delayed diagnosis and consumption of tissue samples) without reported injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Biocare Medical, LLC is recalling 8 units of the 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component (Catalog Number: HP604H). The affected product is identified by Lot Number 041619-4 and has an expiration date of 2020/10. The recall was initiated because the firm identified that the product has no staining capability.
The product was distributed in Texas, Massachusetts, Tennessee, Missouri, and Indiana. If used in a clinical setting with controls, the lack of staining may result in invalid test results, specifically where a positive control would observe no staining. The clinical impact of using this product may include the consumption of patient tissue samples and a delay in diagnosis.
Consumers and healthcare facilities should stop using the affected product and contact Biocare Medical, LLC for further instructions or a return.
The recalled product
- Product
- 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
- Manufacturer
- Biocare Medical, LLC
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Number: 041619-4
- Expiration Date: 2020/10
Distribution
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