Recall of Magellan Diagnostics' LeadCare Plus Blood Lead Test Kit
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Magellan Diagnostics, Inc. is recalling its LeadCare Plus Blood Lead Test Kit due to reports of unexpectedly elevated results from certain third-party devices, which may cause false positive lead tests and unnecessary testing.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 7, 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, cpsc, Devices.
Recall Article: LeadCare Plus Blood Lead Test Kit
What Happened
Magellan Diagnostics, Inc. is initiating a voluntary recall of the LeadCare Plus Blood Lead Test Kit because customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices for testing. This issue may lead to false positive lead results, causing delayed results and additional unnecessary testing.
Which Products Are Affected
The affected product is the LeadCare Plus Blood Lead Test Kit, Catalog Number: 82-0004, with UDI-DI: 00850355006031. This recall includes all lots and all sublots, with approximately 136 units affected. The product was distributed nationwide in the US and to countries including Argentina, Australia, and others.
What You Should Do
Consumers with the affected LeadCare Plus Blood Lead Test Kit should contact Magellan Diagnostics, Inc. for instructions, as the recall was initiated via letter. The firm's address is 101 Billerica Ave Bldg 4, North Billerica, MA 01862-1271.
Why This Matters
This recall matters because false positive results could result in unnecessary medical testing and delays in accurate diagnosis, potentially impacting patient care.
Source
This information is from the FDA recall notice, recall number Z-1894-2026. For more details, refer to the FDA website.
Original source: FDA Official Notice ↗
Related FDA Recalls
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Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,344 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.