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Architect 25-OH Vitamin D
- Starting date:
- December 18, 2012
- Posting date:
- February 4, 2013
- 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-20167
Recalled Products
- Architect 25-OH Vitamin D
Reason
Abbott has confirmed that the Architect 25-OH Vitamin D Assay has the potential to generate falsely elevated or falsely depressed results when the assay is used with various Architect Reaction Vessel (RV) (ln 7C15-01) lots. The issue is due to an interaction between the Architect 25-OH Vitamin D Assay and the resin lots used to produce the impacted RV lots. Patient results can be affected if the impacted RV lots are mixed with non-impacted RV lots in the Architect Hopper and used to test Architect 25-OH Vitamin D. There is no product performance issue with the Architect 25-OH Vitamin D Assay when using non-impacted RV lots.
Affected products
A. Architect 25-OH Vitamin D
Lot or serial number
All Lots
Model or catalog number
- 3L52-25
- 3L52-35
Companies
- Manufacturer
- Abbott GMBH and Co. K.G.