Recall record at a glance
| Official record | Z-0285-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Magellan Diagnostics, Inc. |
| Report date | Nov 7, 2018 |
| Recall initiation date | Aug 8, 2018 |
| Quantity | 1,465 kits |
| Location | North Billerica, MA, United States |
Official product description
Magellan LeadCare II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II Blood Lead Test Kit is for in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and treatment reagent of the test kit are specific for lead only. Contents of the LeadCare II Blood Lead Test Kit must only be used with a LeadCare II Analyzer.
Why the product was recalled
Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values will generate results of HIGH (>65 ¿g/dL). Results for patient testing with this lot will be displayed as HIGH.
Distribution information
Worldwide distribution: US (Nationwide) and countries of: Spain and South Africa.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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