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U.S. Department of Health and Human Services

Class 3 Device Recall IMMULITE 2000 Vitamin B12 Kit

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 Class 3 Device Recall IMMULITE 2000 Vitamin B12 Kitsee related information
Date Initiated by FirmJanuary 24, 2005
Date PostedFebruary 11, 2005
Recall Status1 Terminated 3 on July 12, 2005
Recall NumberZ-0537-05
Recall Event ID 31084
510(K)NumberK993251 
Product Classification Radioassay, Vitamin B12 - Product Code CDD
ProductIMMULITE 2000 Vitamin B12 Kit, Catalog # L2KVB2, L2KVB6, kit lot 186.
Code Information IMMULITE 2000 Vitamin B12 Kit, Catalog # L2KVB2, L2KVB6, kit lot 186.
FEI Number 3005250747
Recalling Firm/
Manufacturer		 Diagnostic Products Corp
5210 Pacific Concourse Dr
Los Angeles CA 90045-6900
For Additional Information ContactSteve Iland
310-645-8200 Ext. 7434
Manufacturer Reason
for Recall		A low CPS limit was not incorporated in the kit barcode for IMMULITE 2000 Vitamin B12 L2KVB 2, 6 kit lot 186 only.
FDA Determined
Cause 2		Other
ActionDomestic customers were notified on January 24, 2005, via telephone and strted receiving a fax-back form and a technical Bulletin on January 25, 2005. Foreign consignees were notified via email and/or Fax.
Quantity in Commerce189 kits
DistributionAL, CA, CO, FL, IL, KS, LA, NY, MA, MD, MI, MS, NC, NE, NM, OH, PA, TN, TX, UT, WA, and Australia, Czech Republic, France, Germany, Netherlands, Portugal, Puerto Rico, Sweden, Turkey, UK, Venzuela
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CDD
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