ISE Electrolyte Reference — Class II medical device recall Z-2136-2020
Terminated recall by Beckman Coulter Inc., reported 2020-06-03, distributed nationwide. Electrolyte reference reagent, used for clinical laboratory testing to determine CO2 in human serum or plasma
| Recall number | Z-2136-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2020-01-29 |
| Classified | 2020-05-28 |
| Reported by FDA | 2020-06-03 |
| Terminated | 2021-04-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, JP, LB, SA, TW |
| Quantity | 2,738 vials |
| UPC / GTIN / UDI-DI | 15099590202491 |
| Lot numbers | M909206 |
| Model numbers | A28937 |
Product
ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quantitative determination of carbon dioxide in human serum or plasma.
Reason for recall
Electrolyte reference reagent, used for clinical laboratory testing to determine CO2 in human serum or plasma for diagnosis and treatment of potentially serious disorders associated with changes in the body acid-base balance, has a low pH and may cause CO2 calibration failures, high CO2 quality control recoveries, and false high patient results which can lead to delay in treatment.
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-2136-2020. 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.