Open, Classified

Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).

FDA Recall Z-1257-2023 · Posted 2023-03-15

Recall StatusOpen, Classified

Product CodeJJE

Date Initiated2023-01-26

Product Quantity4,137 devices (990 U.S. and 3,147 OUS)

Reason for Recall

An increased incidence of damage to the nut band from a new vendor (Boamax) has led to an increased volume of complaints from consignees regarding wash arm motion failures, system check failures, and/or assay performance leading to a remote probability of delayed results or reporting erroneous patient results. The subject nut bands were found to not meet the firm's specifications for hardness and had the incorrect material grain direction. Affected instruments were manufactured from December 28, 2017 to October 19, 2022 or had their nut bands replaced during the same period.

Firm Action

The recalling firm issued letters dated 1/19/2023 beginning 1/26/2023 via both email and first class mail. The letter explained the issue, which included photographs, impact, and the actions to be taken. The consignee was to inspect the wash arm lead screw nut band for damage following the instructions listed in Appendix B of the letter. This inspection was to be repeated during weekly maintenance until the affected nut band has been replaced. If the nut band appears to be intact and undamaged. the consignee may continue normal operation of the instrument. If Wash Arm Motion Errors are observed or if the nut band appears to be damaged in any way, specific instructions are provided. The recalling firm will replace the affected nut bands for all Access 2 Immunoassay Systems listed in Appendix A of the letter. A service representative will contact the consignee to schedule the wash arm lead screw nut band replacement. The information in the notification is to be shared with the laboratory staff and retained as part of the laboratory Quality System documentation. If the affected device has been forwarded to another laboratory, the consignee is requested to provide them a copy of the letter. Response to the notification is requested either electronically or manually using the enclosed response form within 10 days.

Root Cause

Component change control

Distribution Pattern

Worldwide and Nationwide Distribution. There was government/military distribution. Foreign distribution was made to Algeria, Andorra, Australia, Azerbaijan, Bangladesh, Belarus, Belgium, Bonaire, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, France, Georgia, Germany, Ghana, Gibraltar, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, Lebanon, Libya, Lithuania, Macao, Malawi, Malaysia, Maldives, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, U.A.E, Uganda, Ukraine, United Kingdom, Uruguay, Vietnam, Yemen, Zambia, and Zimbabwe.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121214ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEMBeckman Coulter, Inc. · 2013-06-14 K060256UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEMBeckman Coulter, Inc. · 2006-02-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.