Date Initiated by Firm |
January 04, 2017 |
Create Date |
March 09, 2017 |
Recall Status1 |
Terminated 3 on July 18, 2019 |
Recall Number |
Z-1419-2017 |
Recall Event ID |
76212 |
510(K)Number |
K932955
|
Product Classification |
Radioimmunoassay, progesterone - Product Code JLS
|
Product |
Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743
Product Usage: For in vitro diagnostic use in the quantitative determination of progesterone in serum and using the ADVIA Centaur¿, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems
|
Code Information |
16193BB 16200BA 16214BA 16235BB 16250BA 16270BA 16291BA 16319AA |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc 333 Coney St East Walpole MA 02032-1516
|
For Additional Information Contact |
508-668-5000
|
Manufacturer Reason for Recall |
DHEA-S causes falsely elevated progesterone results.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Siemens sent an Urgent Medical Device Correction (UMDC) letter dated January 4, 2017 to all affected Siemens Healthcare Diagnostics customers in the United States dated . An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on January 4, 2017. These letters identified the affected product problem and actions to be taken. For questions contact your local Siemens Customer Care Center or your local Siemens Technical support. |
Quantity in Commerce |
1148 |
Distribution |
US Nationwide distribution including Puerto Rico |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = JLS and Original Applicant = CIBA CORNING DIAGNOSTICS CORP.
|