Reported Nov 30, 2016 · Terminated
AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow…
Beckman Coulter Inc.
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: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- AQUIOS Lyse Reagent Kit, Catalog No
- B23538 Product UsageAQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists of two reagents used by AQUIOS flow cytometers to prepare whole blood samples for analysis of white blood cells
- Lot codes and dates
- 6040014K 6040015K
- Amount recalled
- 2367 units total (207 units in US)
Where it was sold
- Nationwide
Why it was recalled
Beckman Coulter is recalling the AQUIOS Lyse Reagent Kit because it may lead to an increased generation of notifications and flags when used on the AQUIOS CL when running the AQUIOS Tetra application. The issue could lead to an increase in the number of samples requiring review and re-runs with a potential delay to the reporting of results. Depending on the specimen age, a new blood specimen may be required.
This product could cause temporary or reversible health problems — stop using it.
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