Z-0291-2014Class II

Access 2 Immunoassay System, Part Number: 81600N The Access Immunoassay System is an in vitro diagnostic...

Name: Z-0291-2014 Access 2 Immunoassay System, Part Number: 81600N The Access Immunoassay System is an in vitro diagnostic...
Creator: Beckman Coulter Inc.
Published: 2013-09-12
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-09-12 / Terminated

FDA source

Beckman Coulter Inc. began a recall of Access 2 Immunoassay System, Part Number: 81600N The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or... on 2013-09-12. FDA classified it as Class II and gives the reason as "Beckman Coulter is recalling the Access 2 Immunoassay System because they determined that the fuses in the system may be of the wrong amperage". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0291-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-12
Posted: 2013-11-14
Terminated: 2013-11-14
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access 2 Immunoassay System, Part Number: 81600N The Access 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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Beckman Coulter is recalling the Access 2 Immunoassay System because they determined that the fuses in the system may be of the wrong amperage.
FDA root cause: Mixed-up of materials/components
Action: A phone call was made on 9/12/13 to customer who received the Access 2 System. The phone script explains the problem identified of a possible wrong fuse and may result in failure of the fuse to operate properly. Customer was instructed that their Field Service Engineer, will call them back the following week to check on their system and replace the fuses if necessary. If you have any questions concerning this information, please call 952-393-8546.
Quantity in commerce: 8 units total (1 unit in the US)
Distribution: Worldwide distribution: US (nationwide) in the state of: TX and countries of: Colombia, Hong Kong and Korea.
Product codes and lots: Serial Numbers: 508801, 508802, 508803, 508804, 508805, 508806, 508807, 508810

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0291-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0291-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-14

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)