IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872, IVD --- Siem
FDA device recall Z-1518-2014 · posted 2014-04-25 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics
- Reason for recall
- Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays.
- Action taken
- Urgent Medical Device Correction Letters (dated 12/20/13) and effectiveness check response forms were sent to customers on 12/20/13 via FedEx to inform them of the issue. Customers were requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within thirty (30) days. Field service personnel were sent a support document describing the issue and instructing them how to deal with customer questions.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- JHR
- Quantity affected
- 18,489 units
- Distribution
- Worldwide distribution.
- Date initiated
- 2013-12-20
- Date posted
- 2014-04-25
- Date terminated
- 2018-05-18
- Location
- Tarrytown, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMMULITE TOTAL IGE (K931703) | Diagnostic Products Corp. | 1993-08-16 |