Recall Z-1390-2012 ยท JFT Fluorometric, Cortisol
Siemens Healthcare Diagnostics, Inc
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.
| Date | Apr 9, 2012 (initiated Mar 6, 2012) |
| Status | Terminated |
| Reason | Cortisol Assay reagent kit lots do not meet onboard stability and calibration interval claims |
| Root cause | Component design/selection |
| 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 |
| Quantity | Total: 40023. 50 Test Kits = 21734;250 Test Kits= 15879;250 REF Test Kits= 2410 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962559 | ACS CORTISOL IMMUNOASSAY Ciba Corning Diagnostics Corp., Nov 5, 1996 |