IMMULITE 2000. An Automated, Quantitative Immunoassay… recallZ-0994-05 · DPC Cirrus · initiated Apr 22, 2005
Terminated All recalls posted in July 2005
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 DPC Cirrus 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
The Transport Chain is used to move a Reaction Tube within the Immulite 2000. It goes on to state the error condition that occurs due to a false trip of the home sensor.
FDA root cause category: Other
What the company is doing
The firm became aware of the problem on 4/19 and conducted tests on 4/22/05. A service alert for field service engineers and Immulite 2000 distributors was prepared on 4/22/05.
Recall details
- Recall number
- Z-0994-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 22, 2005
- Posted by the FDA
- Jul 16, 2005
- Recalling firm
- DPC Cirrus
- Quantity
- There are 941 units in the United States and 3014 units in the international market.
- Product code
- JJE
- FDA submissions
- K970227
- Distribution
- worldwide
Product description
IMMULITE 2000. An Automated, Quantitative Immunoassay Analyzer for In Vitro Diagnostic Use. Manufactured by DPC Cirrus Inc., Flanders, NJ 07836
Code information (models, lots, serial numbers)
All analyzers; all serial numbers.
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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