Biocare Medical Recalls CD99 In Vitro Diagnostic Reagent Lots
Biocare Medical is recalling specific lots of CD99 in vitro diagnostic reagents because staining intensity has decreased over time, potentially affecting shelf life.
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. The hazard involves a potential failure to meet labeled shelf life due to decreased staining intensity, which is a quality issue without reported injuries or illnesses, fitting the Moderate criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Biocare Medical, LLC is recalling specific lots of CD99 in vitro diagnostic reagents (Catalog number PM008 AA). The product is used to provide adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology methods.
The recall was initiated because a drop in staining intensity over time has been observed in these lots. As a result, the affected units may not meet their labeled shelf life.
The recalled lots are 110912, 041913, 120313, and 110314. The distribution was worldwide, including the United States (specifically TX, KS, OK, NJ, LA, GA, NC, SC, and VA) and the countries of Spain, Austria, Ecuador, Dominican Republic, Vietnam, Kuwait, Hungary, and Israel. Users should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology methods.
- Manufacturer
- Biocare Medical, LLC
- Hazard
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 (9)
- Catalog number PM008 AA
- Lot numbers: 110912
- Exp 2015/11
- 041913
- Expiry 2016/04
- 120313
- Expiry 2016/12
- 110314
- Expiry 2017/11.
Distribution
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