Medical Device Calibrator Recalled for Incorrect Platelet Value Assignments
Siemens Healthcare has recalled 2,020 units of its ADVIA hematology calibrator due to incorrect platelet value assignments that could affect test accuracy. The calibrator is used in laboratories worldwide.
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 an FDA Class II recall of a diagnostic instrument with incorrect calibration that could affect test accuracy. No illnesses, injuries, or hospitalizations have been reported; the hazard is the risk of misdiagnosis from inaccurate platelet values, qualifying as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. has recalled the ADVIA 120/2120/2120i SETpoint Calibrator due to incorrect platelet (PLT) value assignments. The affected units, totaling 2,020 units, bear lot numbers SP251033 and SP251043 and are identified by Siemens Material Number 10312285.
The incorrect platelet value assignments could result in inaccurate test results, affecting laboratories worldwide. The devices were distributed throughout the United States and to 23 other countries including Canada, Japan, Australia, Brazil, and others. Healthcare facilities and diagnostic laboratories using these calibrators may be affected.
Siemens Healthcare has initiated this Class II recall. Healthcare providers using affected units should contact Siemens Healthcare Diagnostics for instructions regarding return, replacement, or remediation of the recalled calibrators to ensure accurate laboratory testing.
The recalled product
- Product
- ADVIA¿ 120/2120/2120i SETpoint Calibrator
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- mis-calibration
- incorrect-test-values
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 10312285
- UDI: 00630414224343
- 00630414224343
- Lot No. SP251033
- SP251043.
Distribution
Distributed nationwide across the United States.
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