—#135907

Product

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.

FDA product code: GIF — Diluent, Blood Cell
Device class: Class 1
Medical specialty: Hematology
510(k) numbers: K081930, K120771
Affected lot / code info: Lot No. 3099980 - 3512190, expiration dates: 17 April 2015 - 26 August 2016.

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

An Urgent Medical Device Recall letter dated 4/13/15 was sent to customers who purchased the Coulter DxH Diluent. The letter informs customers that 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 letter informs customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Customer Support Center via http://www.beckmancoulter.com/customersupport/support or call (800) 526-7694 in the US and Canada. Customers outside the US and Canada are instructed to contact their local Beckman Coulter Representative.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2015-04-13
Posted by FDA: 2015-05-15
Terminated: 2015-10-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #135907. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.