CDC asks states to classify cases as “suspect,” “probable,” or “confirmed” based on several factors. CDC accepts the state’s classification.
CDC defines a person with a “suspect” case as anyone with a blood lead level of 3.5 μg/dL or higher detected through capillary or unspecified testing (not yet confirmed through venous blood testing) within three months of consuming a recalled product. Capillary and venous testing are both commonly used to test blood for lead levels. However, capillary testing might give a falsely high result. Venous testing is more accurate.
CDC defines a person with a “probable” case as anyone with a blood lead level of 3.5 μg/dL or higher detected through venous testing within three months of consuming a recalled product. People with a “probable” case:
- might not have had a follow-up assessment to rule out other potential sources of lead exposure or
- might have had a follow-up assessment completed, but the results indicated there were other potential sources of lead exposure (for example., lead-based paint).
CDC defines a person with a “confirmed case” as anyone with a blood lead level of 3.5 μg/dL or higher:
- Detected through venous testing within three months of consuming a recalled product and
- must have had a follow-up assessment that ruled out other potential sources as the likely cause of lead exposure.
Please note that as the investigation progresses, cases might move to different case categories. For example, a state may initially classify a case as “suspect,” but later determine that the case meets the criteria for being a “confirmed” case. In addition, these simplified definitions might not capture all the nuances of the case definition. We ask that states use our official case definition when classifying cases submitted to CDC. For more information, see CDC’s Lead Poisoning Outbreak Linked to Cinnamon Applesauce Pouches – Case Definition.
Please note that CDC and FDA have different data sources, so the counts reported by each agency might not match. In addition, some people who were affected by the contaminated product might be counted in numbers reported by both FDA and CDC, so the numbers should not be added together. FDA relies on self-reported information submitted by healthcare providers, consumers, and some state partners who submitted an adverse event report to FDA. The reports were submitted as an initial step in determining if a product is a potential shared source of exposure amongst complainants.
