Recall Z-1370-2015— BD Biosciences, Systems & Reagents

Name: FDA recall Z-1370-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-06

Class II · Terminated

Class II FDA medical device recall by BD Biosciences, Systems & Reagents, initiated 2015-03-06, terminated 2016-04-04. It names one FDA 510(k) clearance: K980858. Product: BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.. Reason: 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..

Recalling firm: BD Biosciences, Systems & Reagents
Classification: Class II
Status: Terminated
Initiated: 2015-03-06
Terminated: 2016-04-04
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K980858 — MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTIONBecton Dickinson Immunocytometry Systems·cleared 1998-05-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.