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Coat-A-Count IRMA TSH Kit IKTSX
- Starting date:
- November 23, 2012
- Posting date:
- December 24, 2012
- 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-25903
Recalled Products
- Coat-A-Count IRMA TSH Kit IKTSX
Reason
Siemens Healthcare Diagnostics has confirmed an under-recovery of dose values with some vials of Coat-A-Count IRMA TSH calibrators tsi4 (level b), tsi5 (level c), tsi8 (level f), and tsi9 (level g) lot 035, in the listed reagent kit lots for product code IKTSX.
Affected products
A. Coat-A-Count IRMA TSH Kit IKTSX
Lot or serial number
742, 743
Model or catalog number
IKTSX
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
1550 Appleby Lane
Burlington
L7L 6X7
CANADA