Z-3039-2011

Dimension Calcium Flex Reagent is used on the Dimension clinical chemistry system as an in vitro diagnostic...

Name: Z-3039-2011 Dimension Calcium Flex Reagent is used on the Dimension clinical chemistry system as an in vitro diagnostic...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2011-07-19
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2011-07-19 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Calcium Flex Reagent is used on the Dimension clinical chemistry system as an in vitro diagnostic test intended for the quantitive determination of... on 2011-07-19. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3039-2011
Status: Terminated
Initiated: 2011-07-19
Posted: 2011-08-19
Terminated: 2013-12-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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 root cause: 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.
Product codes and lots: Catalog # DF23A; Lot # EA2153

Product code JJE

K860021Class IDimension(tm) Clinical Chemistry SystemE.I. Dupont DE Nemours & Co., Inc. / cleared 1986-02-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)