Food, drugs, devices › Beckman Coulter Inc.
Device recall: Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quantitat
Beckman Coulter Inc. (Brea, CA) initiated this device recall on 6 Nov 2017; FDA lists 3 product records under event 78613, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 4 Nov 2019. Initiation: voluntary: firm initiated. Beckman Coulter Inc. has 216 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Beckman Coulter Inc., Brea, CA.
Reason for recall
"Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment."
Distribution
"Worldwide Distribution -- US, Argentina, Canada, Chile, China, Columbia, Costa Rica, France, Georgia, Germany, Ghana, Greece, Hong Kong, India, Italy, Japan, Kazakhstan, Mexico, Morocco, Myanmar,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0308-2018 | Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids. | 227 units | Class III | Terminated | 10 Jan 2018 |
| Z-0309-2018 | Access 2 Immunoassay System, Remanufactured, Catalog Number 386220. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids. | 3 units | Class III | Terminated | 10 Jan 2018 |
| Z-0310-2018 | UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids. | 2 units | Class III | Terminated | 10 Jan 2018 |
Context
Other enforcement events for Beckman Coulter Inc.
All 216 events for Beckman Coulter Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution -- US, Argentina, Canada, Chile, China, Columbia, Costa Rica, France, Georgia, Germany, Ghana, Greece, Hong Kong, India, Italy, Japan, Kazakhstan, Mexico, Morocco, Myanmar,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 Nov 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.