Date Initiated by Firm | June 16, 2011 |
Date Posted | May 08, 2012 |
Recall Status1 |
Terminated 3 on May 08, 2012 |
Recall Number | Z-1497-2012 |
Recall Event ID |
61610 |
510(K)Number | K862140 |
Product Classification |
Manual antimicrobial susceptibility test systems - Product Code JWY
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Product | MicroScan Dried Overnight Gram Negative Panels;
Panel type: Neg Urine Combo 55; Catalog Number B1017-409.
Siemens Healthcare Diagnostics,
West Sacramento, CA. |
Code Information |
lot code 2011-06-09. |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 2040 Enterprise Blvd West Sacramento CA 95691-3427
|
For Additional Information Contact | Leslie Ardizone 916-374-0375 |
Manufacturer Reason for Recall | Three lots were confirmed to not meet performance claims due to random non-biological contamination which is only apparent (precipated) after inoculation of the panels. |
FDA Determined Cause 2 | Process control |
Action | Customer Notification letters were sent to all customers of the three MicroScan panels by traceable mail. The letter identified the affected product and asked customers to discard any remaining inventory in addition to contacting customer service for replacement product. The letter also recommended that customers consider the need to review previous test results, conduct patient follow-up, and or repeat tests as needed. Customers were to complete and return the customer reply card to confirm that they received and understood the recall communication. |
Quantity in Commerce | 687 boxes (20 panels per box). |
Distribution | Worldwide Distribution -- US, Turkey, Poland, and Great Britain. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JWY
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