25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay
FDA device recall Z-0697-2013 · posted 2013-01-18 · Terminated
Recall details
- Recalling firm
- IDS (Immunodiagnostic Systems Ltd.)
- 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.
- Action taken
- IDS sent a recall notification letter on November 7, 2012 to all customers that received the the 25-Hydroxy Vitamin D EIA (AC-57F1). The letter informed the customers of the problem identified and the action to be taken. Customers are instructed to complete the attached Recall and Acknowledgement Form and fax back to Immunodiagnostic Systems Inc. Customers with questions are instructed to contact their local IDS office.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MRG
- Quantity affected
- 675 units
- Distribution
- US Nationwide Distribution
- Date initiated
- 2012-11-07
- Date posted
- 2013-01-18
- Date terminated
- 2013-05-31
- Location
- Washington, United Kingdom
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OCTEIA 25-HYDROXY VITAMIN D (K021163) | Immunodiagnostic Systems , Ltd. | 2002-05-10 |