Recall Z-2470-2020— Siemens Healthcare Diagnostics Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics Inc., initiated 2020-05-15, terminated 2022-08-12. It names one FDA 510(k) clearance: K970227. Product: Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended for professional use in a laboratory environment only.. Reason: Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenance potentially causing liquid waste can leak onto the floor, creating a slip and fall hazard.
- Recalling firm
- Siemens Healthcare Diagnostics Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-05-15
- Terminated
- 2022-08-12
- Firm location
- Flanders, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended for professional use in a laboratory environment only.
Reason for recall
Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenance potentially causing liquid waste can leak onto the floor, creating a slip and fall hazard
Data sourced from openFDA. This site is unofficial and independent of the FDA.