Recall Z-2437-2018— Siemens Healthcare Diagnostics, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2018-03-21, terminated 2020-06-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Dimension Vista¿ MULTI 1 SDIL, KD693, SMN# 10469971. Reason: The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the system, due to a reduced volume of diluent being pipetted from the vial..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-21
- Terminated
- 2020-06-12
- Firm location
- Newark, DE, United States
Product description
Dimension Vista¿ MULTI 1 SDIL, KD693, SMN# 10469971
Reason for recall
The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the system, due to a reduced volume of diluent being pipetted from the vial.
Data sourced from openFDA. This site is unofficial and independent of the FDA.