Z-0810-2007

Roche PTH (parathyroid hormone test system) for use in conjunction with Roche cobas e 411, cobas e 601...

Name: Z-0810-2007 Roche PTH (parathyroid hormone test system) for use in conjunction with Roche cobas e 411, cobas e 601...
Creator: Roche Diagnostics Corp.
Published: 2007-04-19
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2007-04-19 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of 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... on 2007-04-19. The reason FDA records is "Negative bias caused by hemolysis interference at the low end of the reference range could cause erroneous diagnosis of hypoparathyroidism". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0810-2007
Status: Terminated
Initiated: 2007-04-19
Posted: 2007-05-16
Terminated: 2008-06-11
Recalling firm: Roche Diagnostics GmbH
Product: 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.
Product code: CEW Radioimmunoassay, Parathyroid Hormone
Reason for recall: Negative bias caused by hemolysis interference at the low end of the reference range could cause erroneous diagnosis of hypoparathyroidism.
FDA root cause: Other
Action: The firm issued a letter dated 04/19/07 to all users informing them of the change in the hemoglobin interference claim.
Quantity in commerce: 14,503
Distribution: Nationwide.
Product codes and lots: 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.

Product code CEW

K992680Class IIElecsys Parathyroid Hormone Test SystemRoche Diagnostics Corp. / cleared 1999-09-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)