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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 073 04 17 000
Date submitted: 4/19/2017
Manufacturer:Abbott
Device Type:ARCHITECT SHBG Reagents
Description:IVD Test Reagent/Kits, Clinical Chemistry
Medical Device Identifier:List Numbers: 8K26‐20, 8K26‐25
Multiple affected Lot numbers of the are provided in the attached FSN
Reason of Field Safety Corrective Action: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.
Remedy Action:1) Immediately discontinue use of the Potassium EDTA specimen tube type with the ARCHITECT SHBG assay according to your laboratory procedures.
2) Please review this letter with your Medical Director to ensure they are aware of the issue and determine if a review of results previously generated using the Potassium EDTA specimen tube type is necessary.
3) If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter.
4) Please complete and return the Customer Reply Form.
5) Please retain this letter for your laboratory records.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:179916BC83205
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf