Z-1710-2017Class II

Access 2 assay Immunoassay System, Remanufactured, Part No. 386220

Name: Z-1710-2017 Access 2 assay Immunoassay System, Remanufactured, Part No. 386220
Creator: Beckman Coulter Inc.
Published: 2017-03-07
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-03-07 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of Access 2 assay Immunoassay System, Remanufactured, Part No. 386220 Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro... on 2017-03-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1710-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-07
Posted: 2017-03-15
Terminated: 2018-03-01
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: 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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: software
FDA root cause: Software Design Change
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.
Quantity in commerce: 851 units total for all products (291 units in US)
Distribution: 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
Product codes and lots: Serial No. 501012,501110,501190,501224,501294,501371,501394,501403,501440, 501443,501490,501501,501673,501681,501693,501861,501920,501926, 501936,501970,502165,502196,502319,502331,502332,502368,502458, 502475,502506,502543,502549,502556,502574,502640,502647,502651, 502791,502843,502848,503153,503279,503313,503354,503384,503392, 503424,503543,503627,503678,504046,504071,504072,504092,504112, 504195,504322,504365,504370,504756,504767,504902,505042,505195, 505251,505254,505644,505795,505840,505947,506002,506026,506108, 506119,506153,506187,506371,506406,506560,506586,506664,506708, 506766,506786,506837,506846,507039,507120,507161,507162,507214, 507229,507248,507282,507353,507397,507480,507511,507604,507619, 507842,507929,508019,508096,508179,508227,508313,508334,508412, 508478,508509,508516,508767,509051,509087,509113,509164,509253, 509297,509632,509837,510049,511042,511047,511180,511383,700024, 800321,800341,800443,800608,800611,800650,800849

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1710-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1709-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-04
Z-1710-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-04
Z-1711-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-04

Product code JJE

K922823Class IIAccess Theophylline Immunoassay ReagentsBio-Rad Laboratories, Inc. / cleared 1992-08-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)