25-Hydroxy Vitamin D EIA — Class II medical device recall Z-0697-2013
Terminated recall by IDS (Immunodiagnostic Systems Ltd.), reported 2013-01-23, distributed nationwide. Immunodiagnostic Systems is recalling the 25-Hydroxy Vitamin D EIA, AC-57F1 because the QC report was found to
| Recall number | Z-0697-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | IDS (Immunodiagnostic Systems Ltd.), Washington, N/A, United Kingdom |
| Recall initiated | 2012-11-07 |
| Classified | 2013-01-17 |
| Reported by FDA | 2013-01-23 |
| Terminated | 2013-05-31 |
| Distributed | Nationwide (US) |
| Quantity | 675 units |
| Lot numbers | 17628 |
| Model numbers | AC-57F1 |
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 used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in adult populations.
Reason for recall
Immunodiagnostic Systems is recalling the 25-Hydroxy Vitamin D EIA, AC-57F1 because the QC report was found to have an erroneous calibrator value assigned. The value of 24.4 ng/mL for calibrator 4 was stated on the QC report, however the correct value should have read 28.4 ng/mL.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0697-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.