Home / Recalls / BD Biosciences, Systems & Reagents / Z-1370-2015

Z-1370-2015 Class II Terminated

Recalled by BD Biosciences, Systems & Reagents — San Jose, CA

FDA device recall Z-1370-2015 was initiated by BD Biosciences, Systems & Reagents on March 6, 2015 and is designated Class II. 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. The recall status is terminated (terminated April 4, 2016). Affected quantity: 72 devices.

Recall Details

Product Type
Devices
Report Date
April 8, 2015
Initiation Date
March 6, 2015
Termination Date
April 4, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
72 devices

Product Description

BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.

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.

Distribution Pattern

Worldwide Distribution -US including TX, NJ, and OK and Internationally to Hong Kong, Japan, Singopore, and Belguim

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.

Other recalls by BD Biosciences, Systems & Reagents

  • Z-2090-2015 Class III — BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD F (June 15, 2015)
  • Z-1375-2015 Class II — CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent (March 23, 2015)
  • Z-1002-2015 Class II — Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in (December 19, 2014)
  • Z-1000-2015 Class II — CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Sin (December 19, 2014)
  • Z-2233-2014 Class III — BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete pro (July 18, 2014)
  • Z-1977-2014 Class II — BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for (June 6, 2014)
  • Z-1536-2014 Class II — Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against huma (April 4, 2014)
  • Z-2397-2012 Class II — BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 (June 29, 2012)

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