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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 Recall
Dimension Calcium Flex Reagent
see related information
Date Posted August 19, 2011
Recall Status1 Terminated on December 27, 2013
Recall Number Z-3039-2011
Recall Event ID 59391
Premarket Notification
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, Delaware 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/UNDETERMINED: Pending
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = E.I. DUPONT DE NEMOURS & CO., INC.
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