Summary
The FDA issued a Class I for LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098 by Magellan Diagnostics, Inc.. Reason: Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the und.
Details
Source
Device Recall
External ID
Z-1954-2021
Action Date
2021-07-07
Status
Terminated
Category
device
Product Description
LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
Lot/Code Info: Lot Numbers/Expiration Date: 2011MU - 25MAR22. 1st expansion 6/21/2021: 2104MU - 25AUG22; 2108MU - 31MAR22.
Quantity Affected: 441 kits (192 tests/kit = 84,672 tests)
Reason for Recall
Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.
Distribution
Worldwide distribution. US nationwide including Puerto Rico; Canada, Vietnam, India, Italy, Peru, New Zealand, Australia, Hong Kong, and Philippines.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-07
Company
North Billerica, MA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 52 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Magellan Diagnostics, Inc. has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Magellan Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Magellan Diagnostics, Inc. have FDA actions?
Magellan Diagnostics, Inc. has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1954-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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