FDA Device recall Z-2136-2020
ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quantitative determinatio…
- FDA Device
- Class II
- terminated
- Published 2020-06-03
On 2020-06-03 the FDA classified a Class II recall of ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quantitative determinatio… by Beckman Coulter, citing electrolyte reference reagent, used for clinical laboratory testing to determine CO2 in human serum or plasma for diagnosis and treatment of potentially serious disorders associat….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2136-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-29 |
| Published | 2020-06-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Beckman Coulter |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot Number: M909206 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2136-2020%22
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