FDA Recall of LeadCare Ultra Blood Lead Test Kit
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Magellan Diagnostics is voluntarily recalling the LeadCare Ultra Blood Lead Test Kit due to reports of unexpectedly elevated results, which could lead to false positives and unnecessary testing.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 8, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
Magellan Diagnostics, Inc. is recalling the LeadCare Ultra Blood Lead Test Kit because customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices for testing. This issue may cause false positive lead results, leading to delayed results and additional unnecessary testing.
Which Products Are Affected
The affected product is the LeadCare Ultra Blood Lead Test Kit with Catalog Number: 70-8098 and UDI-DI: 00850355006024. It includes sensors (8 containers of 24 each; 192 tests), treatment reagent tubes (8 containers of 24 each; 192 tests), a calibration button (1), Lead Control Level 1 (1 at 2 mL), and Lead Control Level 2 (1 at 2 mL). The recall involves all lots and all sublots, with a quantity of 284 units. The product was distributed worldwide, including US Nationwide and countries such as Argentina, Australia, and others.
What You Should Do
Consumers who have received the initial firm notification letter should follow the instructions provided in that letter. For further information, contact the recalling firm, Magellan Diagnostics, Inc., located at 101 Billerica Ave Bldg 4, North Billerica, MA 01862-1271.
Why This Matters
This recall is significant because false positive results could lead to unnecessary medical testing, potentially causing inconvenience and additional healthcare burdens for consumers. It highlights the importance of accurate diagnostic tools in public health.
Source
Attribution: FDA Recall Number Z-1895-2026. For more information, visit the FDA website at https://www.fda.gov/.
Original source: FDA Official Notice ↗
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