Blood lead test kits recalled over mislabeled calibration buttons

Plain-English summary

The LeadCare II Blood Lead Test Kit, catalog number 70-6762, is being recalled. The LeadCare II Blood Lead Test System relies on electrochemistry and a sensor to detect lead in whole blood, and the kit is supplied with sensors, treatment reagent and other materials.

Calibration Buttons used in the kitting process were incorrectly labelled as Lot 2323M for lot 2333M. Magellan states the use of a mislabelled calibration button with lot 2333 can lead to delayed, erroneously high or erroneously low results.

The recall covers 1,774 units across impacted lot and sublot numbers including 2333M. The product was distributed nationwide in the United States. The FDA has classified the action as Class II.

Blood lead testing is used heavily in paediatric screening, so a wrong result in either direction matters. Laboratories holding affected kits should follow Magellan's instructions.

The recalled product

Product

The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The LeadCare¿ II Test Kit is provided with the following materials: " Sensors (2 Containers of 24 sensors each; 48 tests) " Treatment Reagent Tubes (2 packag

Manufacturer

Magellan Diagnostics, Inc.

Category

Medical Device — Diagnostic test

Hazard

• mislabeled-component
• erroneous-results
• lead-testing
• calibration

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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