Abbott Recalls ARCHITECT SHBG Reagent Due to Specimen Tube Interference
Abbott Laboratories is recalling 7,981 kits of ARCHITECT SHBG Reagent because using Potassium EDTA specimen tubes may cause falsely decreased test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states no illnesses or injuries have been reported. The hazard is a potential for inaccurate test results (falsely decreased values) rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Abbott Laboratories is recalling 7,981 kits of ARCHITECT SHBG Reagent. The product is a chemiluminescent microparticle immunoassay used to measure sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT iSystem. The recall covers specific lot numbers distributed worldwide, including the United States and numerous international markets.
The recall was initiated because the firm identified that ARCHITECT SHBG results generated using Potassium EDTA specimen tubes may demonstrate a negative shift relative to results generated with serum. This interference creates a potential for falsely decreased ARCHITECT SHBG results when the assay is used with the Potassium EDTA specimen tube type.
Healthcare facilities and laboratories that have received the affected lots should stop using the reagent and contact Abbott Laboratories for further instructions. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- 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…
- Manufacturer
- Abbott Laboratories
- Affected units
- 7,981
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- List number: 8K26-20
- Lot Numbers: 01916E000
- 00316F000
- 01816G000
- 00916I000
- 07316I000
- 00916L000
- List Number: 8K26-25
- Lot Numbers: 01816E000
- 00216F000
- 01716G000
- 00816I000
- 07216I000
Distribution
Distributed nationwide across the United States.
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