Z-2241-2020Class II

Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9, REF 387687 ( UDI...

Name: Z-2241-2020 Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9, REF 387687 ( UDI...
Creator: Beckman Coulter Inc.
Published: 2019-04-30
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2019-04-30 / Terminated

FDA source

Beckman Coulter Inc. began a recall of Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9, REF 387687 ( UDI: 15099590231842) the Access Family of Immunoassay Systems... on 2019-04-30. FDA classified it as Class II and gives the reason as "The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830, Free T4-REF...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2241-2020
Classification: Class II
Status: Terminated
Initiated: 2019-04-30
Posted: 2020-06-02
Terminated: 2021-12-28
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9, REF 387687 ( UDI: 15099590231842) the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i systems.
Product code: NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Reason for recall: The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, and TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin.
FDA root cause: Other
Action: On 04/30/2019, an Urgent Medical Device Letter was sent via mail to affected consignees. Customers were instructed to access the updated Instructions for Use (IFU) Limitations and Interferences sections for the six affected Access immunoassays on the firm's website. Additionally they ask customers to do the following: 1) Share the information with laboratory staff and retain the notification as part of their laboratory Quality System documentation. If any of the affected product(s) have been forwarded to another laboratory, they are to provide them with a copy of the Urgent Medical Device Recall letter. 2) Respond within 10 days either electronically (if received communication via email) or manually (complete and return an enclosed Response Form). If there are any questions regarding the notice, contact the Customer Support Center: website: http://www.beckmancoulter.com By phone: call 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact the local firm representative.
Quantity in commerce: 150,887
Distribution: US Distribution: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusett, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico New York, North Carolina, North Dakota, Ohio, Oklahoma Oregon, Pennsylvania, Rhode Island, South Carolina,South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming. US Territories: American Samoa, Guam, and Puerto Rico. OUS Distribution: Algeria, Andorra, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Djibouti, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Gibraltar, Greece, Guam, Guatemala, Guyana, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Liberia, Lithuania, Malawi, Malaysia, Mayotte, Mexico, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, Netherlands Antillean, New Zealand, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, San Marino, Serbia, Sierra Leone, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Zambia, and Zimbabwe.
Product codes and lots: Catalog Number: 387687; all lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2241-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2237-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2238-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2239-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2240-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2241-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2242-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02

Product code NIG

K033038Class IIGi Monitor and Gi Monitor Calibrators on the Access Immunoassay Systems, Model 387687, 387688Beckman Coulter, Inc. / cleared 2003-12-29

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)