Z-0308-2018Class III

Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative...

Name: Z-0308-2018 Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative...
Creator: Beckman Coulter Inc.
Published: 2017-11-06
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-11-06 / Terminated / root cause: design

FDA source

Beckman Coulter Inc. began a recall of Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of... on 2017-11-06. FDA classified it as Class III and gives the reason as "Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment". 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-0308-2018
Classification: Class III
Status: Terminated
Initiated: 2017-11-06
Posted: 2018-01-03
Terminated: 2019-11-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access 2 Immunoassay System, Catalog Number 81600N. 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: Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.
Root cause tag: design
FDA root cause: Device Design
Action: An Urgent Medical Device Recall letter, dated November 6, 2017, were sent to the affected customers via mail. The letter identifies the affected device, the reason for recall, impact, and actions to be taken. The firm states that customers may continue to operate their system normally. Customers are instructed to contact Technical Support if a device on the Access 2 instrument needs alignment. The alignment tool is only to be used by the Beckman Coulter service personnel and Beckman Coulter trained biomedical engineers. A Beckman Coulter service rep will contact customers to schedule a service visit. Customers are to share this information with their staff and retain a copy of the letter. Customers are to respond via one of the ways identified. Beckman Coulter should be contacted with any questions regarding the notice.
Quantity in commerce: 227 units
Distribution: Worldwide Distribution -- US, Argentina, Canada, Chile, China, Columbia, Costa Rica, France, Georgia, Germany, Ghana, Greece, Hong Kong, India, Italy, Japan, Kazakhstan, Mexico, Morocco, Myanmar, Nepal, Philippines, Poland, Russia, Rwanda, Saudi Arabia, Slovakia, South Africa, South Korea, Thailand, Turkey, United Kingdom, and Vietnam.
Product codes and lots: Serial/Lot Numbers: 570005-570043, 570047-570049, 570051-570061, 570066-570071, 570073-570091, 570093-570123, 570125, 570126, 570128, 570131-570153, 570156-570203, 570205-570241, 570244-570248, 570250-570252 and 512684

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0308-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0308-2018	Class III	Terminated	Voluntary: Firm initiated	2018-01-10	2018-01-03
Z-0309-2018	Class III	Terminated	Voluntary: Firm initiated	2018-01-10	2018-01-03
Z-0310-2018	Class III	Terminated	Voluntary: Firm initiated	2018-01-10	2018-01-03

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)