Date Initiated by Firm | May 02, 2013 |
Date Posted | June 08, 2013 |
Recall Status1 |
Terminated 3 on September 17, 2013 |
Recall Number | Z-1525-2013 |
Recall Event ID |
65188 |
Product Classification |
Panels, test, susceptibility, antimicrobial - Product Code LTT
|
Product | Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099),
For use in determining quantitative and/or qualitative antimicrobial agent susceptibility. |
Code Information |
Lot: 2013-11-13, Exp 11/13/2013. |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 2040 Enterprise Blvd West Sacramento CA 95691-3427
|
For Additional Information Contact | Leslie Ardizone 916-374-3075 |
Manufacturer Reason for Recall | The product has the potential for false negative or delayed reaction for Arginine (ARG) results. In addition, 42 hour identification panel holds may occur due to a weak ARG reaction. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Siemens sent an Urgent Field Safety Notice dated May 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact your local Siemens Healthcare Diagnostics Representative for information concerning this notice. |
Quantity in Commerce | 683 units |
Distribution | Nationwide Distribution. |
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.
|