IDS 25-Hydroxy Vitamin D EIA Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin D and other hydro
FDA device recall Z-0173-2009 · posted 2008-10-24 · Terminated
Recall details
- Recalling firm
- Immunodiagnostics Systems Inc
- Reason for recall
- A small number of customers have experienced low absorbance values when using kits from this batch.
- Action taken
- All customers who received 25-Hydroxy Vitamin D EIA lot # 60897 were contacted by mail. Customers were instructed to sign a confirming document for having received the notification letter and return via fax. Customers are requested to contact Immunodiagnostic System Inc's office if they have any kits of 60897 remaining in stock. Rather than replacing only the biotin buffer as stated in the letter dated August 2, 2008, Immunodiagnostic Systems Inc. will replace the kit per the letter dated August 8, 2008. Contact Immunodiagnostic System Inc. at 1-480-836-7435 for assistance.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MRG
- Quantity affected
- 691 kits
- Distribution
- Nationwide
- Date initiated
- 2008-08-02
- Date posted
- 2008-10-24
- Date terminated
- 2012-08-13
- Location
- Fountain Hills, AZ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OCTEIA 25-HYDROXY VITAMIN D (K021163) | Immunodiagnostic Systems , Ltd. | 2002-05-10 |