Z-0345-2013Class II

UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. The UniCel DxI...

Name: Z-0345-2013 UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. The UniCel DxI...
Creator: Beckman Coulter Inc.
Published: 2011-08-01
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2011-08-01 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for... on 2011-08-01. FDA classified it as Class II and gives the reason as "The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe assemblies". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0345-2013
Classification: Class II
Status: Terminated
Initiated: 2011-08-01
Posted: 2012-11-19
Terminated: 2012-11-19
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe assemblies.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Beckman Coulter sent a field modification was released in August 2011 which included: - Installing a new aspirate and dispense tubing routing bracket. - Replacing existing aspirate and dispense probe tubing with modified tubing to help eliminatemisrouting of aspirate and dispense probe tubing. During installation the FSE informed the customer: -That aspirate and dispense tubing are different lengths. - That probes are not interchangeable with other instruments once tubing has been modified. - To route probe tubing by referring to the labels on the tubing. An updated service document, Routine Maintenance Changes, A82294B was provided to every customer. For questions regarding this recall call 714-961-4483.
Quantity in commerce: 1,756 units
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Canada, AE, AU, BG, BW, CH, CN, CZ, DE, ES, FR, GB, HK, HR, HU, IN, IT, JO, JP, LB, MA, MX, NL, PL, QA, RO, RU, SK, TN, TR, ZA, AO, AR, AT, BE, CO, DZ, FI, IE, IL, KR, KW, LI, NA, NO, NZ, PF, PH, PR, SE, SG, SZ, TH, TW, VE, VN, and YT.
Product codes and lots: Serial Numbers: 600000 through 602389

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0345-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0345-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0346-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0347-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19

Product code JJE

K023764Class IUnicel Dxi 800 Access Immunoassay System, Model 973100Beckman Coulter, Inc. / cleared 2003-01-28

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)