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Terminated

Access 2 assay Immunoassay System, Remanufactured, Part No. 386220 Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.

FDA Recall Z-1710-2017 · Posted 2017-03-15

Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2017-03-07
Date Terminated2018-03-01
Product Quantity851 units total for all products (291 units in US)

Reason for Recall

Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board that controls motor functions can affect device positioning on the pipettor and incubator belt while the instrument is running. The position errors cause the instrument to stop running and cancel tests that are in process.

Firm Action

An Urgent Medical Device Recall letter was sent on 3/7/17 to inform customers that Beckman Coulter has determined through internal investigation that a circuit board that controls motor functions in the instrument systems listed above can affect device positioning on the pipettor and incubator belt while the instrument is running. Customers are informed of the impact, action to be taken, and the resolution. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions are instructed to contact Customer Technical Support Center: From our website: http://www.beckmancoulter.com By phone: call 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact your local Beckman Coulter representative.

Root Cause

Software Design Change

Distribution Pattern

Affected geographies: Algeria, Austria, Australia, Bangladesh, Bulgaria, Brazil, Canada, China, Costa Rica, Cyprus, Colombia, Czech Republic, El Salvador, France, Germany, Ghana, Greece, Guatemala, India, Indonesia, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Lithuania, Malawi, Mexico, Morocco, Myanmar, Nepal, Oman, Panama, Philippines, Pakistan, Paraguay, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Switzerland, Tunisia, Turkey, United Kingdom, United States, Vietnam, Zimbabwe

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K922823ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTSBio-Rad Laboratories, Inc. · 1992-08-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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