Z-1033-2013Class II

Access 2 Immunoassay System; P/N 107405S 2/12 The Access Immunoassay Systems are in vitro diagnostic devices...

Name: Z-1033-2013 Access 2 Immunoassay System; P/N 107405S 2/12 The Access Immunoassay Systems are in vitro diagnostic devices...
Creator: Beckman Coulter Inc.
Published: 2013-02-12
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-02-12 / Terminated / root cause: design

FDA source

Beckman Coulter Inc. began a recall of Access 2 Immunoassay System; P/N 107405S 2/12 The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or... on 2013-02-12. FDA classified it as Class II and gives the reason as "Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the formation of debris. Debris that is caused by the incubator...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1033-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-12
Posted: 2013-04-01
Terminated: 2013-12-23
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access 2 Immunoassay System; P/N 107405S 2/12 The 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 initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the formation of debris. Debris that is caused by the incubator belt pulley rubbing against the light shield can fall into the reaction vessels (RVs) and present a risk of erroneous test results.
Root cause tag: design
FDA root cause: Device Design
Action: Beckman Coulter sent an "Urgent Product Correction" letter dated February 12, 2013 via mail and email to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to place your Access system in the Ready or Not Ready mode. Lift the cover (as you do to access the probes) and look at the left side of the incubator unit under the peripump by the aspirate probe, if you see a silver pulley, immediately discontinue use and contact Technical Support also check for QC failures and system check failures; If you see a white pulley, this is the correct part and you can resume normal activity. Beckman will replace the metal pulley with the plastic pulley if you verified the your instrument has the silver pulley. The customers were also instructed to share this information with staff; and complete and return enclosed Response Form within 10 days. If you have any questions regarding this notice, please contact Technical support from the website: http://www.beckmancoulter.com or by phone at: 1-800-854-3633 in the United States and Canada.
Quantity in commerce: 3500 units
Distribution: Worldwide distribution: USA (nationwide) and countries of: Aurstria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Djibouti, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
Product codes and lots: Part # 81600N, 386220, A12900, A69186; All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1033-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1032-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-10	2013-04-01
Z-1033-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-10	2013-04-01
Z-1034-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-10	2013-04-01
Z-1035-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-10	2013-04-01

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)