Z-1956-2016Class II

Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used for the...

Name: Z-1956-2016 Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used for the...
Creator: Beckman Coulter Inc.
Published: 2016-05-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-05-17 / Terminated

FDA source

Beckman Coulter Inc. began a recall of Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used for the quantitative, semi-quantitative, or qualitative... on 2016-05-17. FDA classified it as Class II and gives the reason as "Due to the lack of updated thermal components, these instruments may be more susceptible to the internal case temperature exceeding the 18 to 36 degrees Celsius operating range, causing SYS flags. The instrument will...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1956-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-17
Posted: 2018-10-11
Terminated: 2016-08-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Due to the lack of updated thermal components, these instruments may be more susceptible to the internal case temperature exceeding the 18 to 36 degrees Celsius operating range, causing SYS flags. The instrument will not report results until the internal case temperature returns to the operating range. This situation may cause a delay in the reporting of patient results.
FDA root cause: Under Investigation by firm
Action: An Urgent Medical Device Recall letter dated 5/17/16 was sent to customers to inform them that Beckman Coulter is recalling the Access 2 Immunoassay System, Remanufactured instrument, because it may not have all the updated thermal components installed. The letter informs customers of the impact and actions to be taken. The letter informs the customers that their Service Representative will contact them to schedule an onsite visit to inspect their instrument and update as needed. 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: http://www.beckmancoulter.com, 1-800-854-3633 in the United States and Canada. Customers outside the United States and Canada are instructed to contact their local Beckman Coulter representative.
Quantity in commerce: 4 units total (1 unit in US)
Distribution: US, Morocco, Venezuela
Product codes and lots: Serial No. 505143, 504805, 501368, 504231

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1956-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1956-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-13

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)