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Architect Free T4 Reagent
- Starting date:
- May 1, 2017
- Posting date:
- September 5, 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-64408
Reason
Recent data generated by Abbott have determined that the measuring interval is 0.40 ng/dl to 5.00 ng/dl. Measuring interval is defined as the range of values in ng/dl which meets the limits of acceptable performance for both imprecision and linearity. The current measuring interval for list numbers 7K65-29, 7K65-34 and 7K65-39 is 0.40 ng/dl to 6.00 ng/dl. A new FT4 assay file and updated package insert will be created reflecting the new measuring interval of 0.40 ng/dl to 5.00 ng/dl to be used with list numbers 7K65-29, 7K65-34 and 7K65-39.
Affected products
Architect Free T4 Reagent
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 7K65-29
- 7K65-34
- 7K65-39
Companies
- Manufacturer
-
ABBOTT IRELAND DIAGNOSTICS DIVISION
LISNAMUCK, LONGFORD
IRELAND