Siemens ADVIA Centaur Cortisol Assay Cat. Nos. 04610138 (1 0321 026)- 250 Test kit 04610049(10309078)- 50 Test kit 04611
FDA device recall Z-1390-2012 · posted 2012-04-09 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Reason for recall
- Cortisol Assay reagent kit lots do not meet onboard stability and calibration interval claims
- Action taken
- 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
- Status
- Terminated
- Product code
- JFT
- Quantity affected
- 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,
- Date initiated
- 2012-03-06
- Date posted
- 2012-04-09
- Date terminated
- 2015-06-26
- Location
- East Walpole, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACS CORTISOL IMMUNOASSAY (K962559) | Ciba Corning Diagnostics Corp. | 1996-11-05 |