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Terminated

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

FDA Recall Z-1370-2015 · Posted 2015-06-26

Recalling FirmBD Biosciences, Systems & Reagents
Recall StatusTerminated
Product CodeOYE
Date Initiated2015-03-06
Date Terminated2016-04-04
Product Quantity72 devices

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.

Firm 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.

Root Cause

Mixed-up of materials/components

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K980858MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTIONBecton Dickinson Immunocytometry Systems · 1998-05-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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