MAGELLAN DIAGNOSTICS LeadCare II Blood Lead Test Kits recalled due to temperature exposure between June 2021 and August 2021. Product may not work properly if stored in high temperatures.
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
MAGELLAN DIAGNOSTICS is recalling LeadCare II Blood Lead Test Kits that were shipped between June 1, 2021 and September 30, 2021. These kits could have been affected by high temperatures during shipping, potentially making them less effective for blood lead testing.
The test kits were exposed to higher temperatures during shipping from June 2021 to August 2021. This exposure could reduce the test's accuracy, meaning results might not correctly measure blood lead levels.
Healthcare facilities and labs that received these test kits between June 1, 2021 and September 30, 2021. Users at highest risk are those testing blood lead levels in patients using these kits.
Check for the model number 70-6762 or GTIN 00850355006000 on the kit. These kits were shipped between June 1, 2021 and September 30, 2021.
Look for the model number 70-6762 or GTIN 00850355006000 on the test kit packaging.
The test kits were exposed to higher temperatures during shipping from June 2021 to August 2021, which could reduce their effectiveness for blood lead testing.
The recall record does not specify a remedy, so no action is required beyond checking if you have the kit.
The recall indicates potential reduced effectiveness, not safety risks like injury or illness. The hazard is low risk.
We’ve drafted a message you can send MAGELLAN DIAGNOSTICS to request your refund or repair — edit it as you like.
Subject: Recall Z-1597-2022 — MAGELLAN DIAGNOSTICS MAGELLAN DIAGNOSTICS Hello, I own a MAGELLAN DIAGNOSTICS that is covered by recall Z-1597-2022 from MAGELLAN DIAGNOSTICS. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
