LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultr...
Reason for Recall / Hazard
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.
Product Description & Identification
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 Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)
Affected Products
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 Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)
Additional Source Details
| Field | Value |
|---|---|
| City | North Billerica |
| State | MA |
| Event id | 98502 |
| Address 1 | 101 Billerica Ave Bldg 4 |
| Address 2 | N/A |
| Code info | Catalog Number: 70-8098; UDI-DI: 00850355006024; ALL lots and ALL sublots; |
| Postal code | 01862-1271 |
| Report date | 20260429 |
| Product type | Devices |
| Product quantity | 284 |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260313 |
| Initial firm notification | Letter |
| Center classification date | 20260417 |
Overview
- Recalling FirmMagellan Diagnostics, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide and the countries of Argentina, Australia, Bhutan, Bolivia, Canada, Chile, Diego Garcia, Ecuador, Eritrea, Georgia, Ghana, Guam, Guatemala, Haiti, Hong Kong, India, Indonesia, Israel, Italy, Ivory Coast, Japan, Kyrgyzstan, Mexico, Nepal, Peru, Philippines, South Africa, South Korea, Spain, UAE, Uruguay, Vietnam.