AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer sys...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0648-2017.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0648-2017.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0648-2017.
Beckman Coulter Inc.
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If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Beckman Coulter Inc. Recall FAQ
Beckman Coulter Inc. is the subject of a diagnostic devices safety report: AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer sys.... The notice was published on October 19, 2016 by the U.S. Food and Drug Administration (FDA). Approximately 2,367 units are potentially affected.