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iChem 10 SG Urine Chemistry Strips (2014-12-09)
- Starting date:
- December 9, 2014
- Posting date:
- December 29, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-43039
Recalled Products
iChem 10 SG Urine Chemistry Strips
Reason
The identified lots of iChem 10 SG Urine Chemistry Strips (only lot 510033A was shipped to Canada) may have leukocyte pads that are more sensitive at the first reporting range of 1+, corresponding to 25 white blood cells per microliter, leading to false positive leukocyte results for samples that are truly negative.
Affected products
iChem 10 SG Urine Chemistry Strips
Lot or serial number
- 510033A
- 510034A
- 510035A
- 510035B
Model or catalog number
800-7005
Companies
- Manufacturer
-
Iris Diagnostics, a Division of Iris International Inc.
9172 Eton Avenue,
Chatsworth
91311
California
UNITED STATES