—#116185

Product

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.

FDA product code: CEO — Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K861700
Affected lot / code info: Lot numbers DC3078, exp 3/19/13; DA3092, exp 4/2/13; FB3109, exp 4/19/13; BC3127, exp 5/7/13; BB3152, exp 6/1/13; EC3166, exp 6/15/13; BB3190, exp 7/9/13; DA3212, exp 7/31/13; EA3233, exp 8/21/13; FB3260, exp 9/17/13; DA3319, exp 11/15/13; DA3320, exp 11/16/13; GC3337, exp 12/3/13; FB3346, exp 12/12/13; CB4014, exp 1/14/14; and FB4029, exp 1/29/14.

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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 laboratory. Please complete the attached Effectiveness Check form and fax it to the Siemens Technical Solutions Center at (302) 631-8467, to indicate you have received the information. If you have any questions, please contact the Siemens Technical Solutions enter or your local Siemens technical support representative. We apologize for the disruption this situation will cause your laboratory. We are working diligently to resolve this issue with a permanent solution. .

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2013-02-22
Posted by FDA: 2013-04-02
Terminated: 2015-01-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #116185. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.