Recall Z-2138-2023
Beckman Coulter, Inc. · initiated May 31, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
Codes / lots: 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…
Reason for recall
Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-2138-2023
- Initiated
- May 31, 2023
- Posted by FDA
- July 12, 2023
- Product code
- GIF – Diluent, Blood Cell
- Quantity
- 335, 448 units
- Distribution
- 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.
- Recalling firm
- Beckman Coulter, Inc., Miami, FL