IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1… recallZ-1517-2014 · Siemens Healthcare Diagnostics · initiated Dec 20, 2013
Class II Terminated All recalls posted in April 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1517-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 20, 2013
- Posted by the FDA
- Apr 25, 2014
- Recalling firm
- Siemens Healthcare Diagnostics
- Quantity
- 5953 units
- Product code
- JHR
- FDA submissions
- K931703, K960067
- Distribution
- Worldwide distribution.
Product description
IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers - for the quantitative measurement of Total Immunoglobulin type E (IgE) in serum.
Code information (models, lots, serial numbers)
Lots 326 through 333
Other devices under the same FDA submission
1 device cleared under K931703, K960067 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- IMMULITE® 2000 Systems TIE Total IgE 10380873Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D, E)1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 67210).
- Z-1518-2014 · TerminatedIMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagn…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page