| Class 2 Device Recall Access Immunoassay Systems | |
Date Initiated by Firm | February 12, 2013 |
Date Posted | April 01, 2013 |
Recall Status1 |
Terminated 3 on December 23, 2013 |
Recall Number | Z-1034-2013 |
Recall Event ID |
64332 |
510(K)Number | K023049 |
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
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Product | Synchron LXi 725 Clinical System; P/N 107405S
Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. |
Code Information |
Part # A15642; All Serial Numbers |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc. 250 S Kraemer Blvd Brea CA 92821-6232
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For Additional Information Contact | Yung (Dung) Nguyen 714-961-4941 |
Manufacturer Reason for Recall | Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the formation of debris. Debris that is caused by the incubator belt pulley rubbing against the light shield can fall into the reaction vessels (RVs) and present a risk of erroneous test results. |
FDA Determined Cause 2 | Device Design |
Action | Beckman Coulter sent an "Urgent Product Correction" letter dated February 12, 2013 via mail and email to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to place your Access system in the Ready or Not Ready mode. Lift the cover (as you do to access the probes) and look at the left side of the incubator unit under the peripump by the aspirate probe, if you see a silver pulley, immediately discontinue use and contact Technical Support also check for QC failures and system check failures; If you see a white pulley, this is the correct part and you can resume normal activity. Beckman will replace the metal pulley with the plastic pulley if you verified the your instrument has the silver pulley. The customers were also instructed to share this information with staff; and complete and return enclosed Response Form within 10 days.
If you have any questions regarding this notice, please contact Technical support from the website: http://www.beckmancoulter.com or by phone at: 1-800-854-3633 in the United States and Canada. |
Quantity in Commerce | 83 units |
Distribution | Worldwide distribution: USA (nationwide) and countries of: Aurstria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Djibouti, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. |
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 = JJE
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