BD Biosciences, Systems & Reagents: Medical Device Recall in 2015 - (Recall #: Z-1370-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 6, 2015

Date Posted: April 8, 2015

Recall Number: Z-1370-2015

Event ID: 70678

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.

Status: Terminated

Product Quantity: 72 devices

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.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated