FDA Device recall Z-2613-2017
ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination o…
- FDA Device
- Class II
- terminated
- Published 2017-06-28
On 2017-06-28 the FDA classified a Class II recall of ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination o… by Abbott Laboratories, citing 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. The….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2613-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-18 |
| Published | 2017-06-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Abbott Laboratories |
| Distribution | US |
Product
ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT iSystem. The ARCHITECT SHBG assay is used as an aid in the diagnosis of androgen disorders.
Reason
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.
Identifiers
| code_info | List number: 8K26-20, Lot Numbers: 01916E000, 00316F000, 01816G000, 00916I000, 07316I000, 00916L000 ; List Number:…List number: 8K26-20, Lot Numbers: 01916E000, 00316F000, 01816G000, 00916I000, 07316I000, 00916L000 ; List Number: 8K26-25, Lot Numbers: 01816E000, 00216F000, 01716G000, 00816I000, 07216I000 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2613-2017%22
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