|
Class 2 Device Recall IMMULITE IGFI |
|
Date Initiated by Firm |
April 15, 2016 |
Date Posted |
September 16, 2016 |
Recall Status1 |
Terminated 3 on April 20, 2017 |
Recall Number |
Z-2841-2016 |
Recall Event ID |
73995 |
Product Classification |
Radioimmunoassay, human growth hormone - Product Code CFL
|
Product |
IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma. |
Code Information |
SMN Number:10381403 Lot: 411 Expired: 2016-04 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave Tarrytown NY 10591-5005
|
For Additional Information Contact |
914-631-8000
|
Manufacturer Reason for Recall |
24 minutes of incubation is required prior to processing patient samples and for the pretreatment solution to reach full equilibration when using pretreatment solution when using the pretreatment solution (LGFA) contained in the kit.
|
FDA Determined Cause 2 |
Unknown/Undetermined by firm |
Action |
On April 15, 2016, Siemens Healthcare Diagnostics Inc. distributed Urgent Medical Device Correction notices to their domestic customers and Urgent Field Safety Notices to their internationally customers via courier service. Customers are advised to take the following four actions: 1) To continue using IGF-I kit lot 411 and the associated pretreatment solution lot 055 to report patient results, ensure the IGF-I pretreatment solution is allowed to incubate with the patient sample for a minimum of 24 minutes prior to processing on the IMMULITE/IMMULITE 1000 systems. 2) Complete and return the Effectiveness Check Form attached to the letter within 30 days. 3) Please review the letter with your Medical Director. 4) If you have received any complaints of illness or adverse events associated with the product, immediately contact your local Siemens Customer Care Center or your local Siemens technical support representative. If customers have further distributed the product, please retain the letter with your laboratory records, and forward to those who may have received this product. |
Quantity in Commerce |
525 units |
Distribution |
Domestic: IL, FL, NY, OH, LA, MO, MA; International: Canada, others will be inserted |
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.
|
|
|
|