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Terminated

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.

FDA Recall Z-0810-2007 · Posted 2007-05-16

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeCEW
Date Initiated2007-04-19
Date Terminated2008-06-11
Product Quantity14,503

Reason for Recall

Negative bias caused by hemolysis interference at the low end of the reference range could cause erroneous diagnosis of hypoparathyroidism.

Firm Action

The firm issued a letter dated 04/19/07 to all users informing them of the change in the hemoglobin interference claim.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K992680ELECSYS PARATHYROID HORMONE TEST SYSTEMRoche Diagnostics Corp. · 1999-09-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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