Recall Z-0173-2009 ยท MRG System, Test, Vitamin D
Immunodiagnostics Systems Inc
IDS 25-Hydroxy Vitamin D EIA Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in serum or plasma. Ref: AC-57F1 Lot 60897 Exp 2009-08; Immunodiagnostic Systems Ltd, Unit 10, Boldon Business Park, Boldon, Tyne & Wear, NE35. 9PD, UK. Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated
| Date | Oct 24, 2008 (initiated Aug 2, 2008) |
| Status | Terminated |
| Reason | A small number of customers have experienced low absorbance values when using kits from this batch. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 691 kits |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021163 | OCTEIA 25-HYDROXY VITAMIN D Immunodiagnostic Systems , Ltd., May 10, 2002 |