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Leadcare II Analyzer and Test Kits (2017-05-26)
- Starting date:
- May 26, 2017
- Posting date:
- June 13, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-63608
Affected Products
- A. Leadcare II Analyzer Kit
- B. Leadcare II Test Kit
Reason
The LeadCare testing systems may underestimate blood lead levels and give inaccurate results when processing venous blood samples. The LeadCare testing systems can be used with capillary blood samples.
Affected products
A. Leadcare II Analyzer Kit
Lot or serial number
All lots
Model or catalog number
70-6760
Companies
- Manufacturer
-
Magellan Diagnostics, Inc.
101 Billerica Ave., Building 4
North Billerica
01862
Massachusetts
UNITED STATES
B. Leadcare II Test Kit
Lot or serial number
All lots
Model or catalog number
70-6762
Companies
- Manufacturer
-
Magellan Diagnostics, Inc.
101 Billerica Ave., Building 4
North Billerica
01862
Massachusetts
UNITED STATES