Recall Z-1049-2013 ยท CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The Phosphorus (PHOS) method used on the Dimension(R) clinical chemistry system is an in vitro diagnostic test intended for the quantitative measurement of phosphorus in human serum, plasma, and urine.
| Date | Apr 2, 2013 (initiated Feb 22, 2013) |
| Status | Terminated |
| Reason | Siemens Healthcare Diagnostics has initiated a voluntary field action for Dimension(R) PHOS Flex(R) Reagent due to reagent interaction causing falsely depressed Creatinine results when EZCR is processed from open wells that are in close proximity to open wells of PHOS reagent. |
| Root cause | Device Design |
| Action | Siemens sent an Urgent Medical Device Correction letter dated February 22 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action to be taken by Customer: 1. Customers with two or more Dimension systems should perform testing of PHOS and EZCR on separate Dimension systems. 2. Customers with only one Dimension system should discontinue use of either PHOS or EZCR on the Dimension system. Please contact your local sales representative to discuss alternate solutions that will best meet the needs of your laborator |
| Quantity | 60,674 |
| Distribution | Nationwide Distribution including the states of AK, AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K861700 | DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM E.I. Dupont DE Nemours & Co., Inc., Jun 11, 1986 |