Liquid Waste Bottle Kit, Catalog#10386287. The Immulite 2000 and 2000 XPi systems are continuous random-access instrumen
FDA device recall Z-1663-2015 · posted 2015-05-23 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions Diagnostics
- Reason for recall
- The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.
- Action taken
- Siemens Healthcare Diagnostics sent an Urgent Device Correction Letter/Field Correction Effective Check Form dated 3/5/15 via FedEx to their affected customers.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 15 bottles
- Distribution
- Worldwide Distribution.
- Date initiated
- 2015-03-05
- Date posted
- 2015-05-23
- Date terminated
- 2018-01-16
- Location
- Flanders, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER (K970227) | Dpc Cirrus | 1997-04-08 |