Reported Apr 10, 2013 · Terminated
Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The Phosphorus (PHOS) method used on the…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 500 Gbc Dr Ms 514 · Newark, DE · 19702-2466
Is this the product you have?
- 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.
- Lot codes and dates
16 of 16 products
Products covered by this recall # Product as published 1 Lot numbers DC3078, exp 3/19/13 2 DA3092, exp 4/2/13 3 FB3109, exp 4/19/13 4 BC3127, exp 5/7/13 5 BB3152, exp 6/1/13 6 EC3166, exp 6/15/13 7 BB3190, exp 7/9/13 8 DA3212, exp 7/31/13 9 EA3233, exp 8/21/13 10 FB3260, exp 9/17/13 11 DA3319, exp 11/15/13 12 DA3320, exp 11/16/13 13 GC3337, exp 12/3/13 14 FB3346, exp 12/12/13 15 CB4014, exp 1/14/14 16 and FB4029, exp 1/29/14. - Amount recalled
- 60,674
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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