Beckman Coulter Inc. recalls COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an isotonic buffered diluent in conjunction with a…

Recall date

April 13, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1616-2015

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

Worldwide Distribution -- Argentina; Brazil; Brunei Darussalam; Canada; Chile; Colombia; Hong Kong; India; Lebanon; Macao; Mexico; Panama; Philippines; Qatar; Singapore; Taiwan; Thailand; Trinidad and Tobago; United States, including Puerto Rico; and Uruguay.

Why it was recalled

Beckman Coulter has received an increased number of complaints related to Hemoglobin (HGB) on UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems. The use of the DxH Diluent lots listed in the recall notice may eventually result in a compromised HGB chamber.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells.