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Terminated

Siemens ADVIA Centaur Cortisol Assay Cat. Nos. 04610138 (1 0321 026)- 250 Test kit 04610049(10309078)- 50 Test kit 04611509 (1 0335503)- 250 REF Test kit ADVIA Centaur Systems Cortisol: For in vitro diagnostic use in the quantitative determination of cortisol in serum or urine using the ADVIA Centaur and ADVIA Centaur XP systems.

FDA Recall Z-1390-2012 · Posted 2012-04-09

Recalling FirmSiemens Healthcare Diagnostics, Inc
Recall StatusTerminated
Product CodeJFT
Date Initiated2012-03-06
Date Terminated2015-06-26
Product QuantityTotal: 40023. 50 Test Kits = 21734;250 Test Kits= 15879;250 REF Test Kits= 2410

Reason for Recall

Cortisol Assay reagent kit lots do not meet onboard stability and calibration interval claims

Firm Action

The firm, Siemens Healthcare, sent an "Urgent Field Safety Notice" via e-mail to all affected customers on March 6, 2012 in the United States and International. The Urgent Field Safety Notice describe the product, problem, and actions to be taken. The notice instructed the customers to perform daily calibration on all Cortisol reagent kits to maintain consistently accurate quality control and patient values; to complete and return the confirmation fax-back form 'Field Correction Effectiveness Check' via fax to the Technical Solutions Center at (302) 631-7597 and forward this notification to whomever they many have distributed this product. If you have any questions, contact Quality Engineer 5- Quality Systems and Compliance at 508-660-8540 or www.siemens.com/diagnostics.

Root Cause

Component design/selection

Distribution Pattern

Worldwide distributed: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, AUSTRALIA, BANGLADESH, BD, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, EGYPT, GERMANY, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, JAPAN, KOREA, MALAYSIA, MEXICO, NEW ZEALAND, PAKISTAN, PHILIPPINES, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, TAIWAN, THAILAND, URUGUAY, VENEZUELA, and VIETNAM.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K962559ACS CORTISOL IMMUNOASSAYCiba Corning Diagnostics Corp. · 1996-11-05

Official Source

View FDA Recall →

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

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