—#139181

Product

COULTER ISOTON 4 Diluent, Catalog No. 8547148. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as red blood cells and platelets.

FDA product code: GIF — Diluent, Blood Cell
Device class: Class 1
Medical specialty: Hematology
510(k) numbers: K011342, K061616
Affected lot / code info: Lot Numbers: 18203F-18206F.

Why it was recalled

Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the diluent lots may eventually result in a compromised Hgb cuvette.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

An Urgent Medical Device Recall letter dated 7/22/15 was sent to the affected customers to inform them of the issue and actions to take. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions are instructed to contact Beckman Coulter's Customer Support Center, http://www.beckmancoulter.com/customersupport/support, (800) 526-7694 in US and Canada. Customers outside of 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: Distributed US (nationwide) including Puerto Rico and U.S. Virgin Islands and the countries of Bermuda, Canada, Guatemala, Hong Kong, Mexico, Panama, Taiwan, and Trinidad-Tobago.

Timeline

Recall initiated: 2015-07-22
Posted by FDA: 2015-08-28
Terminated: 2015-12-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139181. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.