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U.S. Department of Health and Human Services

Class 2 Device Recall BD Biosciences, Systems, and Reagents

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 Class 2 Device Recall BD Biosciences, Systems, and Reagentssee related information
Date Initiated by FirmMarch 06, 2015
Date PostedJune 26, 2015
Recall Status1 Terminated 3 on April 04, 2016
Recall NumberZ-1370-2015
Recall Event ID 70678
510(K)NumberK980858 
Product Classification Flow cytometric reagents and accessories. - Product Code OYE
ProductBD 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.  
FEI Number 2916837
Recalling Firm/
Manufacturer		 BD Biosciences, Systems & Reagents
2350 Qume Dr
San Jose CA 95131-1812
For Additional Information ContactMelissa Quinn
408-954-6080
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.
FDA Determined
Cause 2		Mixed-up of materials/components
ActionBD 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 Commerce72 devices
DistributionWorldwide Distribution -US including TX, NJ, and OK and Internationally to Hong Kong, Japan, Singopore, and Belguim
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = OYE
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