FDAFDA · Food and drugs·Recall number Z-1629-2022
BECKMAN COULTER, INC. a. COULTER DxH Diff Pack REAGENT, DIFF PK FP DXHCOULTR, Catalog #628020. b. COULTER DxH Cleaner REAGENT, CLEANER FP DXH 10LCOULTR Catalog #628023. c. DxH 500 Series Lyse LYSE, VERSA SOL DXH 500 SERIES(0.5L/KT) Catalog # B36846. d. DxH 500 Series Cleaner CLEANER, COULTER CLENZ DXH 500SERIES (0.5L/KT) Catalog # B36868
Published August 31, 2022 · Recall initiated: May 25, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Distributor
- US Nationwide
- Lot
- GTIN: a. 15099590233716. b. 15099590233747. c. 15099590671860. d. 15099590671877
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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