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.
FDA Recall Z-3039-2011 · Posted 2011-08-19
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Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2011-07-19
Date Terminated2013-12-27
Product Quantity2500 cartons
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.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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