Biocare Medical Recalls D2-40 Lymphatic Marker Due to Incorrect Instructions
Biocare Medical is recalling 19 units of D2-40 Lymphatic Marker because incorrect Instructions for Use were shipped with the product.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is limited to incorrect documentation (Instructions for Use) without reported injuries or illnesses.
Plain-English summary
Biocare Medical, LLC is recalling 19 units of D2-40 (Lymphatic Marker), a mouse monoclonal antibody intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry. The recall was initiated because the firm discovered that incorrect Instructions for Use were shipped with one lot of the product.
The affected product is identified by catalog number PM266AA, lot 030615, and an expiration date of 2018/03. The units were distributed worldwide, including in the United States (specifically in Michigan, South Carolina, North Carolina, Arizona, California, Missouri, and Wisconsin) and in Hungary, Spain, and Austria.
Consumers and laboratories should stop using the affected product and contact Biocare Medical for further instructions or a refund.
The recalled product
- Product
- D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry…
- Manufacturer
- Biocare Medical, LLC
- Hazard
- Affected units
- 19
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 (3)
- Catalog number: PM266AA
- lot 030615
- Expiration: 2018/03.
Distribution
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