| Date Initiated by Firm |
March 06, 2013 |
| Date Posted |
May 08, 2013 |
| Recall Status1 |
Terminated 3 on October 28, 2013 |
| Recall Number |
Z-1272-2013 |
| Recall Event ID |
64699 |
| 510(K)Number |
K091949
|
| Product Classification |
Panels, test, susceptibility, antimicrobial - Product Code LTT
|
| Product |
Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels.
.MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp. |
| Code Information |
All lots within expiration: Lot numbers: 2013-02-24 2013-03-05 2013-03-06 2013-04-03 2013-04-04 2013-04-19 2013-05-01 2013-05-10 2013-05-18 2013-05-21 2013-06-07 2013-06-18 2013-06-25 2013-07-27 2013-08-10 2013-08-23 2013-09-11 2013-09-14 2013-09-28 2013-10-02 2013-11-01 2013-11-02 2013-11-15 2013-11-29 2013-12-07 2013-12-12 2013-12-17 2014-01-04 2014-01-09 2014-01-15 2014-02-01 2014-02-13. |
Recalling Firm/
Manufacturer |
Siemens Healthcare Diagnostics, Inc.
2040 Enterprise Blvd
West Sacramento CA 95691-3427
|
| For Additional Information Contact |
Leslie Ardizone
916-374-0601
|
Manufacturer Reason
for Recall |
Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads with A. agalactiae affecting multiple antimicrobial agents on MicroScan Microbiology Systems.
|
FDA Determined
Cause 2 |
Under Investigation by firm |
| Action |
Siemens Healthcare sent a Urgent Field Safety Notification letter dated March 6, 2013, to all affected customers of MicroScan MICroSTREP plus type 1, who process panels in a Walk Away System. The letter identified the product the problem and the action needed to be taken by the customer.
As stated in our product Instructions for Use, test results should be interpreted in conjunction with the patients medical history, clinical presentation and other findings. We recommend discussing the content of this letter with your laboratory director regarding the need to review previous test results, conduct patient follow-up, and/or repeat testing for testing conducted in the last twelve months.
Confirmation of receipt of this letter is required. Attached you will find a form indicating you have received and understood the information. We would greatly appreciate your assistance in notifying us that you have received the information by taking a moment to complete and return the form below.
If you require further information or assistance, please contact your local Siemens Healthcare Diagnostics Representative. Please forward this notification to anyone to whom you may have distributed this product.
We apologize for the inconvenience that this situation has caused.
For further questions please call 1-800-677-7226 Option 1 (USA/Canada)
Thank you for your patience and continued support. |
| Quantity in Commerce |
21,608 boxes = 432,160 panels |
| 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 = LTT and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS
|
