ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a recall
ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex…
Why was ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a recalled?
Firm 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. There is a potential for falsely decreased ARCHITECT SHBG results to be generated when using the ARCHITECT SHBG assay with the Potassium EDTA specimen tube type.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
List number: 8K26-20, Lot Numbers: 01916E000, 00316F000, 01816G000, 00916I000, 07316I000, 00916L000 ; List Number: 8K26-25, Lot Numbers: 01816E000, 00216F000, 01716G000, 00816I000, 07216I000
- Product
- ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex…
- Recalling firm
- Abbott Laboratories
- Quantity
- 7981 kits
- Distribution
- Worldwide Distribution - USA (nationwide) and to the countries of : ARGENTINA, ARMENIA, AUSTRIA, AZERBAIJAN, BANGLADESH, BARBADOS, BELARUS, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BRUNEI, CANADA, CHINA, CHILE, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DEM. REP. OF THE CON, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, HUNGARY, INDIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JORDAN, KAZAKHSTAN, KUWAIT, LATVIA, LEBANON, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MONTENEGRO, NAMIBIA, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PARAGUAY, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UAE, UNITED KINGDOM, URUGUAY, VIETNAM
- Recall date
- June 28, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)