Roche PTH (parathyroid hormone test system) for use in… recallZ-0810-2007 · Roche Diagnostics Corp. · initiated Apr 19, 2007
Terminated All recalls posted in May 2007
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 Roche Diagnostics 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
Negative bias caused by hemolysis interference at the low end of the reference range could cause erroneous diagnosis of hypoparathyroidism.
FDA root cause category: Other
What the company is doing
The firm issued a letter dated 04/19/07 to all users informing them of the change in the hemoglobin interference claim.
Recall details
- Recall number
- Z-0810-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 19, 2007
- Posted by the FDA
- May 16, 2007
- Recalling firm
- Roche Diagnostics Corp.
- Quantity
- 14,503
- Product code
- CEW
- FDA submissions
- K992680
- Distribution
- Nationwide.
Product description
Roche PTH (parathyroid hormone test system) for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers; catalog no. 11972103122.
Code information (models, lots, serial numbers)
Lots 17723501, exp. 1/31/08; 17723502, exp. 1/31/08; 17642601, exp. 11/30/07; 17642602, exp. 11/30/07; 17450901, exp. 5/31/07; 17450902, exp. 5/31/07 and 17450903, exp. 5/31/07.
Other devices under the same FDA submission
1 device cleared under K992680 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Elecsys PTH Immunoassay 11972103160Roche Diagnostics GmbH · RADIOIMMUNOASSAY, PARATHYROID HORMONE3 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.
How recalls are matched to devices · Editorial policy · Report an error on this page