FDA Recall of LeadCare II Blood Lead Test Kits
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 197,893 units of LeadCare II Blood Lead Test Kits due to reports of unexpectedly elevated results from certain third-party devices.
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 "low" 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, fda, Devices.
What Happened
Magellan Diagnostics, Inc. is recalling the LeadCare II Blood Lead Test Kits 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 products are: (1) LeadCare II Blood Lead Test Kit with Catalog Number 70-6762, (2) LeadCare II 5X Blood Lead Test Kit with Catalog Number 70-8404 (Box containing 5 Test Kits), (3) LeadCare II 9X Blood Lead Test Kit with Catalog Number 70-9000 (Box containing 9 test kits), and (4) LeadCare II 5X Blood Lead Test Kit with Catalog Number 70-6762RUO. The kits include UDI-DI codes: 00850355006000 for Catalog Numbers 70-6762 and 70-6762RUO, 00850355006086 for 70-8404, and 00850355006093 for 70-9000. All lots and sublots are affected, with a total of 197,893 units distributed worldwide, including US Nationwide and countries such as Argentina, Australia, and Canada. The recall was initiated on March 13, 2026, under recall number Z-1893-2026.
What You Should Do
Consumers should stop using the affected LeadCare II Blood Lead Test Kits immediately and contact Magellan Diagnostics, Inc. at their address: 101 Billerica Ave Bldg 4, North Billerica, MA 01862-1271, as the initial notification was made via letter. Follow the firm's instructions for returns or refunds, and refer to the recall number Z-1893-2026 for more details.
Why This Matters
This recall affects blood lead testing accuracy, potentially leading to unnecessary medical testing and delays in proper diagnosis for users worldwide. It highlights the importance of reliable diagnostic devices in healthcare to ensure patient safety and accurate results.
Source
This information is from the FDA recall database, attributed to recall number Z-1893-2026 on the FDA website.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
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 (1,964 characters here).
Similar severity timing
Same severity (low) notices issued closest in time to May 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.