ISE Electrolyte Reference reagent — Class II medical device recall Z-1951-2013
Terminated recall by Beckman Coulter Inc., reported 2013-08-21, distributed nationwide. Beckman Coulter is recalling the Synchron Systems LX20/UniCel DxC ISE Reference Reagent because it has a potas
| Recall number | Z-1951-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2010-09-22 |
| Classified | 2013-08-10 |
| Reported by FDA | 2013-08-21 |
| Terminated | 2013-08-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CH, DE, ES, FR, GB, NL, PL, SE |
| Lot numbers | T006042 |
| Model numbers | 467915, 467935, A28937, A28945 |
Product
ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915. Product Usage: ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems AQUA CAL 1, 2 and 3, are intended for the quantitative determination of potassium concentration in human serum, plasma or urine.
Reason for recall
Beckman Coulter is recalling the Synchron Systems LX20/UniCel DxC ISE Reference Reagent because it has a potassium (K) response near the instrument calibration flag limits and may exceed the limits on some instruments.
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-1951-2013. 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.