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U.S. Department of Health and Human Services

Class 3 Device Recall IDS 25Hydroxy Vitamin D EIA Enzymeimmunoassay

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  Class 3 Device Recall IDS 25Hydroxy Vitamin D EIA Enzymeimmunoassay see related information
Date Initiated by Firm August 02, 2008
Date Posted October 24, 2008
Recall Status1 Terminated 3 on August 13, 2012
Recall Number Z-0173-2009
Recall Event ID 49393
510(K)Number K021163  
Product Classification Vitamin D test system - Product Code MRG
Product 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 metabolites in serum or plasma
Code Information Lot Code #60897
Recalling Firm/
Manufacturer		 Immunodiagnostics Systems Inc
17029 E Enterprise Dr Ste 1
Fountain Hills AZ 85268
Manufacturer Reason
for Recall		 A small number of customers have experienced low absorbance values when using kits from this batch.
FDA Determined
Cause 2		 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 in Commerce 691 kits
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MRG and Original Applicant = IMMUNODIAGNOSTIC SYSTEMS LTD.
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