Siemens magnesium reagent cartridges recalled for false measurement results
Siemens is recalling two lots of Magnesium Flex reagent cartridges due to potential falsely low magnesium measurements. The intermittent error may not be detected by standard quality control procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a diagnostic error that could lead to incorrect patient treatment. Although no illnesses or injuries have been reported, the intermittent nature of the measurement error and potential for undetected false results in clinical care constitutes a risk-of-harm scenario meeting the High category criterion.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling two lots (24057BB and 24064BC) of their Magnesium Flex reagent cartridges (Catalog Number K3057) used in clinical laboratory testing. These cartridges contain 360 tests each and approximately 13,115 units were distributed worldwide.
The recall was initiated due to the potential for falsely low measurements of magnesium in patient plasma samples. Because this measurement error is intermittent rather than consistent, standard quality control procedures may not identify that a patient's results are incorrect, allowing false results to be reported to clinicians.
The affected cartridges were distributed in the United States and internationally to Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Slovenia, and Spain. Healthcare providers and laboratory personnel using these cartridges should contact Siemens Healthcare Diagnostics for guidance on lot verification and replacement.
The recalled product
- Product
- Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- measurement-error
- diagnostic-error
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 (5)
- Siemens Material Number (SMN): 10445158
- Catalog Number: K3057
- UDI-DI: 00842768015694
- Lot numbers: 24057BB
- 24064BC.
Distribution
Distributed nationwide across the United States.
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