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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Calcium Flex Reagent

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  Class 2 Device Recall Dimension Calcium Flex Reagent see related information
Date Initiated by Firm July 19, 2011
Date Posted August 19, 2011
Recall Status1 Terminated 3 on December 27, 2013
Recall Number Z-3039-2011
Recall Event ID 59391
510(K)Number K860021  
Product Classification Analyzer chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Dimension Calcium Flex Reagent is used on the Dimension clinical chemistry system as an in vitro diagnostic test intended for the quantitive determination of calcium activity in human serum, plasma and urine.

Dimension(R) CA Flex(R) reagent is used on the Dimension(R) clinical chemistry system as an in vitro diagnostic test intended for the quantitative determination of calcium activity in human serum, plasma and urine.
Code Information Catalog # DF23A; Lot # EA2153
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information Contact Customer Support
302-631-0516
Manufacturer Reason
for Recall		 Siemens Healthcare Diagnostic has confirmed a high frequency of "Abnormal assay" flags and imprecision. Test results across the assay range may be falsely depressed or elevated, as much as, 1.93 mg/dL at a concentration of 9.26 mg/dL.
FDA Determined
Cause 2		 Other
Action An Urgent Field Safety Notice datey July 2011 was issued to all affected customers. Customers are being advised to immediately discontinue use and discard any remaining inventory of Dimension(R) CA Flex(R0 reagent cartridge - lot EA2153. Replacement order for the affected lot is in process, and will be sent to impacted customers free of charge. Customers were instructed to forward the Field Safety Notice to anyone whom they may have distributed the affected product. For questions regarding this recall call 302-631-6299.
Quantity in Commerce 2500 cartons
Distribution Worldwide Distribution to Guam, Puerto Rico, Chile, Costa Rica, Venezuela, South Korea, Vietnam and domestically to AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MN, MI, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WV, WI, and WY.
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 = JJE and Original Applicant = E.I. DUPONT DE NEMOURS & CO., INC.
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