Biocare Medical Recalls MUM-1 Antibody Lots Due to Staining Intensity Issues
Biocare Medical is recalling three lots of MUM-1 antibody because staining intensity drops over time, potentially affecting diagnostic accuracy.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a performance issue (staining intensity) rather than a direct physical injury or contamination, fitting the 'Moderate' criteria for low-risk or precautionary issues.
Plain-English summary
Biocare Medical LLC is recalling three lots of MUM-1 (Multiple myeloma oncogene-1) antibody, catalog number PRM352 AA. The product is intended for in vitro diagnostic use to help identify and sub-classify lymphoid malignancies. The recall involves 59 units distributed nationwide in the United States and in several international countries, including Kuwait, India, Venezuela, New Zealand, Turkey, and Uruguay.
The recall was initiated because the product may not meet its labeled shelf life. A drop in staining intensity over time has been observed, which could impact the reliability of the diagnostic results. The affected lots are 061013 (expiring 2016/06), 073013 (expiring 2016/07), and 071614 (expiring 2017/07).
Healthcare facilities and laboratories that have purchased these specific lots should stop using the product and contact Biocare Medical for further instructions. This recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; Product Usage: For In Vitro Diagnostic Use. This antibody may be used as a tool for the identification and the sub classification of lymphoid malignancies : Multiple myeloma oncogene-1 (MUM-1) is a protein enco
- Manufacturer
- Biocare Medical Llc
- Affected units
- 59
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 (6)
- Lot 061013
- Exp 2016/06
- Lot 073013
- Exp. 2016/07
- Lot 071614
- Exp. 2017/07.
Distribution
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