FDA Device Recalls

Recalls / —

—#200884

Product

COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells

FDA product code
GIF — Diluent, Blood Cell
Device class
Class 1
Medical specialty
Hematology
Affected lot / code info
UDI DI 150995901HEMDILUENT5R; Container Number: 0001-0401: Lot numbers: Lot Numbers Beginning with 3541: 3541500, 3541510, 3541520, 3541550, 3541610, 3541620, 3541670, 3541690, 3541750, 3541770, 3541790, 3541810, 3541830, 3541860, 3541880, 3541900, 3541910, 3541920, 3541930, 3541940, 3541950, 3541990; Lot Numbers Beginning with 3542: 3542010, 3542030, 3542050, 3542070, 3542110, 3542150, 3542170, 3542180, 3542190, 3542230, 3542250, 3542260, 3542270, 3542310, 3542350, 3542370, 3542450, 3542490, 3542510, 3542530, 3542570, 3542590, 3542610, 3542630, 3542650, 3542670, 3542720, 3542740, 3542760, 3542780, 3542800, 3542820, 3542840, 3542850, 3542900, 3542920, 3542940, 3542960, 3542980; Lot Numbers Beginning with 3543: 3543000, 3543020, 3543040, 3543050, 3543080, 3543120, 3543140, 3543160, 3543170, 3543180, 3543200, 3543220, 3543240, 3543280, 3543300, 3543320, 3543340, 3543360, 3543370, 3543390, 3543410, 3543430, 3543460, 3543480, 3543500, 3543540, 3543560, 3543580, 3543610, 3543850, 3543870, 3543890, 3543910, 3543930, 3543950, 3543970, 3543990; Lot Numbers Beginning with 3544: 3544010, 3544030, 3544040, 3544050, 3544070, 3544090, 3544110, 3544130, 3544150, 3544160, 3544170, 3544190, 3544210, 3544230, 3544250

Why it was recalled

Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice on 05/31/2023 by email and mail. The notice explained the issue, its impact on the patient, and requested the following actions be taken: "Inspect the lot number set up on your instrument(s) and your current inventory with the corresponding container number (see Appendix A). Locate the container number on your diluent reagent 2D or Linear barcode label (see Appendix B). Contact Beckman Coulter Customer Technical Support Organization to replace the affected containers in your current inventory. Consult with your laboratory management to determine whether a retrospective review of results is necessary.

Recalling firm

Firm
Beckman Coulter, Inc.
Address
11800 Sw 147th Ave, Miami, Florida 33196-2500

Distribution

Distribution pattern
Worldwide distribution - US Nationwide and the countries of Argentina, Bolivia (Plurinational State of), Brazil, Canada, Chile, Colombia, Ecuador, Hong Kong, Indonesia, Kuwait, Mexico, Panama, Peru, Puerto Rico, Taiwan, Trinidad and Tobago, Uruguay, and Viet Nam.

Timeline

Recall initiated
2023-05-31
Posted by FDA
2023-07-12
Status
—

Source: openFDA Device Recall endpoint. Recall record ID #200884. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.