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.
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, 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.
Related recalls
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- LowR&D Systems Recalls Vitamin D ELISA Kits Due to Labeling Error
FDA (Devices) · 2018-11-14
- HighRoche Vitamin D Test System Recalled for Falsely Elevated Results
FDA (Devices) · 2018-07-18
- LowOrtho-Clinical Diagnostics Recalls VITROS Vitamin D Calibrators for Biased Results
FDA (Devices) · 2014-03-19
- ModerateSiemens ADVIA Centaur Vitamin D Calibrator Recalled for Negative Bias
FDA (Devices) · 2013-04-24
- HighQualigen Vitamin D Immunoassay Kit Recalled for Inaccurate Test Results
FDA (Devices) · 2017-09-13
- ModeratePhadia Recalls EliA dsDNA Well Kits Due to Potential False Positive Results
FDA (Devices) · 2021-02-17