IMMULITE 2000 Intact PTH kit recallZ-0724-04 · Diagnostic Products Corp · initiated Feb 23, 2004
Terminated All recalls posted in July 2004
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 Diagnostic Products Corp 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
High bias noted in samples collected with EDTA. Indication is to not run samples with EDTA.
FDA root cause category: Other
What the company is doing
Recall was by letter mailed / faxed on February 23, 2004. Users are instructed to remove EDTA plasma samples for consideration for testing and correct instructions in the package insert.
Recall details
- Recall number
- Z-0724-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 23, 2004
- Posted by the FDA
- Jul 20, 2004
- Recalling firm
- Diagnostic Products Corp
- Quantity
- 2416 kits
- Product code
- CEW
- FDA submissions
- K013566
- Distribution
- North America, Central America, South America, Europe, Asia, South Africa, Middle East. Domestic includes: VA Hospital, St. Louis MO VA Medical Center, Denver, CO VA Medical Center, Richmond, VA VA Medical Center, West Haven, CT Walter Reed Army Medical Center, Washington DC
Product description
IMMULITE 2000 Intact PTH kit
Code information (models, lots, serial numbers)
Kit lots L2KPP 117 (exp date Aug 31 2004) and 118 (exp date Oct 31 2004)
Other devices under the same FDA submission
4 devices cleared under K013566 — 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 IPT Intact PTH 10381441Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, PARATHYROID HORMONE1 recall18 reports
- IMMULITE® 2000 Systems IPT Intact PTH 10381442Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, PARATHYROID HORMONE1 recall0 reports
- IMMULITE® Systems PTH CONTROL Intact PTH 10385354Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, PARATHYROID HORMONE1 report
- IMMULITE®/IMMULITE® 1000 Systems iPT Intact PTH 10381399Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, PARATHYROID HORMONE1 report
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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