Siemens Dimension Phosphorus Reagent Cartridge Recalled for Result Interference
Siemens is recalling Dimension Phosphorus reagent cartridges because they can cause falsely low creatinine results when processed near open wells.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary field action for a diagnostic accuracy issue (falsely depressed results) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is conducting a voluntary field action for Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridges (DF61). The recall involves 60,674 units distributed nationwide, including specific states and territories listed in the agency record.
The action was initiated due to a reagent interaction issue. When the EZCR (Creatinine) test is processed from open wells that are in close proximity to open wells of the PHOS reagent, the interaction causes falsely depressed Creatinine results. This is an in vitro diagnostic test intended for the quantitative measurement of phosphorus in human serum, plasma, and urine.
The affected lot numbers are DC3078, DA3092, FB3109, BC3127, BB3152, EC3166, BB3190, DA3212, EA3233, FB3260, DA3319, DA3320, GC3337, FB3346, CB4014, and FB4029. Affected healthcare facilities should stop using these specific lots and follow the instructions provided by Siemens Healthcare Diagnostics for the field action.
The recalled product
- 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.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 60,674
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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