AQUIOS Lyse Reagent Kit — Class II medical device recall Z-0648-2017
Terminated recall by Beckman Coulter Inc., reported 2016-11-30, distributed nationwide. Beckman Coulter is recalling the AQUIOS Lyse Reagent Kit because it may lead to an increased generation of not
| Recall number | Z-0648-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2016-10-19 |
| Classified | 2016-11-21 |
| Reported by FDA | 2016-11-30 |
| Terminated | 2017-02-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, CH, CL, CZ, DE, DK, ES, FI, FR, GB, GH, IT, MY, NL, PL, RO, SE, SK, ZA |
| Model numbers | B23538 |
Product
AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS 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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0648-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.