FDA Recall Database: Class II Recall: LeadCare Ultra Blood Lead Test Kit; Catalog Number:… by Magellan Diagnostics, Inc.

Key facts

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent Tubes (8 containers of 24 each; 192 tests) " Calibration Button (1 @) " Lead (additional items listed in FDA's full record) -- and the recall number Z-1895-2026. If it matches, stop using or distributing it and contact Magellan Diagnostics, Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Magellan Diagnostics, Inc. and the affected product is described in FDA's record as: LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent Tubes (8 containers of 24 each; 192 tests) " Calibration Button (1 @) " Lead (additional items listed in FDA's full record). FDA's stated reason for the recall is: Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.. The recall is tracked under FDA recall number Z-1895-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

Magellan Diagnostics, Inc.’s FDA history

Argus HQ has recorded 3 total FDA actions tied to Magellan Diagnostics, Inc.: 0 warning letters, 3 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What was recalled and why?

Magellan Diagnostics, Inc. recalled LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent Tubes (8 containers of 24 each; 192 tests) " Calibration Button (1 @) " Lead (additional items listed in FDA's full record). FDA's record states the reason for recall as: Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with.

How serious is this recall?

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent Tubes (8 containers of 24 each; 192 tests) " Calibration Button (1 @) ".

Has Magellan Diagnostics, Inc. had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 3 total FDA actions tied to Magellan Diagnostics, Inc., including 3 recalls and 0 warning letters.

Related enforcement actions