IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products
FDA device recall Z-1517-2014 · 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
- 5953 units
- Distribution
- Worldwide distribution.
- Date initiated
- 2013-12-20
- Date posted
- 2014-04-25
- Date terminated
- 2018-05-18
- Location
- Tarrytown, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMMILITE TOTAL IGE (K960067) | Diagnostic Products Corp. | 1996-02-14 |
| IMMULITE TOTAL IGE (K931703) | Diagnostic Products Corp. | 1993-08-16 |