Magellan Diagnostics, Inc.: The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The LeadCare¿ II Te
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Magellan Diagnostics, Inc.
- 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 packages of 24 tubes each; 48 tests) " Heparinized Capillary Tubes/Plungers (50) " Transfer Droppers (50) " Calibration Button (1) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)
- Reason / hazard
- Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mislabeled calibration Button with Lot #2333 can lead to delayed or erroneous high or erroneous low results.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution.
- Recall initiated
- 2024-02-23
- Code info
- Product Name: LeadCare¿ II Blood Lead Test Kit; Catalog Number: 70-6762; Impacted Lot/Sublot Numbers: 2333M, 2333M-01, 2333M-02, 2333M-03, 2333M-04, 2333M-05, 2333M-06, 2333M-07, 2333M-08, 2333M-09, 2333M-10, 2333M-11; Device Identifier: (01)00850355006000;
- Product quantity
- 1,774 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- North Billerica
- State
- MA
- Country
- United States
- Event id
- 97858
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