Immulite 2000 recallZ-1316-2014 · Siemens Medical Solutions Diagnostics · initiated Feb 3, 2014
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 Medical Solutions 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
There is a potential for incorrect results to be reported from processing of a sample tube.
FDA root cause category: Device Design
What the company is doing
Siemens sent an Urgent Medical Device Correction letter dated February 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers was told how to correct the issue if it has occurred, and how to prevent the issue from occurring. The completed form should be faxed to (302) 631-7597. Any questions can be directed to Siemens Technical Support Representative. Siemens plans to implement a correction at a later time.
Recall details
- Recall number
- Z-1316-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 3, 2014
- Posted by the FDA
- Apr 2, 2014
- Recalling firm
- Siemens Medical Solutions Diagnostics
- Quantity
- 1006 units
- Product code
- JJE
- FDA submissions
- K970227
- Distribution
- Nationwide and Foreign Distribution.
Product description
IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing. The VersaCell system is a robotic sample-moving device that supports an interface to a number of laboratory analysis systems, such as the IMMULITE 2000
Code information (models, lots, serial numbers)
IMMULITE 2000: 10380062, 10380061,10380079, 10380065, 10360210, 10283632 IMMULITE 2000XPi: P010053/S007; 10373214 VersaCell: 10380063, 10389945, 10380064, 10287115, 10793839
Other devices under the same FDA submission
3 devices cleared under K970227 — 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 XPi Immunoassay System 10373214Siemens Healthcare Diagnostics Products Ltd · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE286 reports
- VersaCell® X3 10793839Siemens Healthcare Diagnostics Products Ltd · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE3 reports
- IMMULITE® 2000 Systems TSH Third Generation TSH 10381665Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE2 reports
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.
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