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Architect I System - SHBG Assay
- Starting date:
- April 20, 2017
- Posting date:
- May 16, 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-63290
Reason
Abbott has identified that architect SHBG results generated with the potassium EDTA specimen tube type may demonstrate a negative shift relative to results generated with serum. SHBG dimer destabilization in EDTA could result in low SHBG measurements by immunoassay. All in-date lots of current reagent inventory are impacted.
Affected products
Architect I System - SHBG Assay
Lot or serial number
00216F000
00316F000
00816I000
00916I000
00916L000
01716G000
01816E000
01816G000
01916E000
07216I000
07316I000
Model or catalog number
8K26-20
8K26-25
Companies
- Manufacturer
-
Abbott GmbH and Co. K.G.
Max Planck Ring 2
Wiesbaden
65205
GERMANY