Reported Aug 31, 2022 · Ongoing

BECKMAN COULTER, INC. a. COULTER DxH Diff Pack REAGENT, DIFF PK FP DXHCOULTR, Catalog #628020. b. COULTER DxH Cleaner…

Mckesson Medical-Surgical Inc. Corporate Office

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Mckesson Medical-Surgical Inc. Corporate Office · 9954 Maryland Drive · Richmond, VA · 23233

Is this the product you have?

4 of 4 products

Products covered by this recall
Model / numberProduct as published
628020.COULTER DxH Diff Pack REAGENT, DIFF PK FP DXHCOULTR
628023.COULTER DxH Cleaner REAGENT, CLEANER FP DXH 10LCOULTR
B36846.DxH 500 Series Lyse LYSE, VERSA SOL DXH 500 SERIES(0.5L/KT)
B36868DxH 500 Series Cleaner CLEANER, COULTER CLENZ DXH 500SERIES (0.5L/KT)
Lot codes and dates
  • GTINa. 15099590233716. b. 15099590233747. c. 15099590671860. d. 15099590671877
Amount recalled
a. 11 b. 13 c. 15 d. 33

This recall covers 55 products

The agency filed one notice per product. You are reading one of them; the other 54 are below.

42 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.