IDS Recalls 25-Hydroxy Vitamin D EIA Due to QC Error
IDS is recalling 25-Hydroxy Vitamin D EIA kits because a quality control report contained an incorrect calibrator value.
What this means for you
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, which typically corresponds to a moderate severity. The issue is a documentation error in a QC report rather than a direct physical hazard or confirmed patient harm.
Plain-English summary
Immunodiagnostic Systems (IDS) is recalling the 25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. The recall involves 675 units distributed nationwide in the United States. The specific lot affected is #17628.
The recall was initiated because a quality control (QC) report was found to have an erroneous calibrator value assigned. The report stated the value for calibrator 4 as 24.4 ng/mL, but the correct value should have been 28.4 ng/mL.
This product is an enzyme immunoassay intended for the quantitative determination of 25-hydroxyvitamin D in human serum or plasma. The source text does not specify further instructions for consumers or healthcare providers beyond the recall notice.
The recalled product
- Product
- 25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay intended for the quantitative determination of 25-hydroxyvitamin D (25-OH D) and other hydroxylated metabolites in human serum or plasma. Results are to be
- Manufacturer
- IDS (Immunodiagnostic Systems Ltd.)
- Hazard
- Affected units
- 675
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 (1)
- Lot # 17628
Distribution
Distributed nationwide across the United States.
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