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Class 2 Device Recall BD Biosciences, Systems, and Reagents |
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Date Initiated by Firm |
March 06, 2015 |
Date Posted |
June 26, 2015 |
Recall Status1 |
Terminated 3 on April 04, 2016 |
Recall Number |
Z-1370-2015 |
Recall Event ID |
70678 |
510(K)Number |
K980858
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Product Classification |
Flow cytometric reagents and accessories. - Product Code OYE
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Product |
BD FACSCalibur; Catalog Numbers 342973, 342975, 34976
In vitro Diagnostics Use. |
Code Information |
Serial Nos. E34297300656, E34297300657, E34297300659, E34297300660, E34297300661, E34297300666, E34297300667, E34297300668, E34297300669, E34297300670, E34297300671, E34297300673, E34297300675, E34297300676, E34297300677, E34297300678 E34297502563, E34297502564, E34297502565, E34297502566, E34297502567, E34297502568, E34297502569, E34297502570, E34297502571, E34297502572, E34297502573, E34297502574, E34297502575, E34297502576, E34297502577, E34297502578, E34297502579, E34297502580, E34297502581, E34297502583, E34297502584, E34297502585, E34297502586, E34297502587, E34297502588, E34297502589, E34297502590, E34297502591, E34297502592, E34297502593, E34297502594, E34297502595, E34297502596, E34297502597, E34297502599, E34297502600, E34297502601, E34297502602, E34297502603, E34297502604, E34297502605, E34297502606, E34297502607, E34297502608, E34297502612, E34297502613, E34297502619, E34297502620, E34297502621, E34297502629, E34297600499, E34297600501, E34297600502, E34297600503, E34297600507, E34297600508. |
Recalling Firm/ Manufacturer |
BD Biosciences, Systems & Reagents 2350 Qume Dr San Jose CA 95131-1812
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For Additional Information Contact |
Melissa Quinn 408-954-6080
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Manufacturer Reason for Recall |
The circuit breakers on some BD FACSCalibur instruments may have the incorrect rated amperage (20 amps instead of 2 amps) causing the circuit breaker to fail to open in an over-current situation.
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FDA Determined Cause 2 |
Mixed-up of materials/components |
Action |
BD Biosciences sent an Important Product Recall letter on March 6, 2015 by certified mail and Field Change Notification (FCN FCB15-01-660312 directing Field Service Engineers to correct the circuit breaker is in process. Customers with questions were instruct to contact BD Customer Support at 1-877-232-8995 (prompt 2) in the United States. For customers outside the US were instructed to contact their local BD Biosciences representative or distributor. For questions regarding this recall call 408-954-6080. |
Quantity in Commerce |
72 devices |
Distribution |
Worldwide Distribution -US including TX, NJ, and OK and Internationally to Hong Kong, Japan, Singopore, and Belguim |
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 = OYE and Original Applicant = BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS
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