The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog

FDA device recall Z-1077-2019 · posted 2019-03-30 · Open, Classified

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during the creation of an aliquot and lead to incorrect results being generated. Affected samples typically yield non-reproducible falsely decreased results by up to 100%, however the potential for falsely elevated results cannot be ruled out.

Action taken

On 12/05/18, the firm mailed Urgent Medical Device Recall notices to all consignees. In order to prevent this error from occurring, do not load racks onto the SPU while samples are being processed from the automation line. Either of the following options can be followed to avoid the error: 1) Pause the automation line before loading of any racks onto the SPU. a) To pause the automation line and load racks on the SPU, use the following steps: i) Set the Lab Automation System (LAS) Mode to "Offline" (1) Return to the Main Menu (F9) (2) Select Configure (F8) (3) Select LIS/LAS (F6) (4) Select LAS (F2) (5) In the dropdown menu, select "Offline" and press OK (F1) ii) Load samples onto the SPU iii) Wait until all racks from the SPU are fully aspirated and moved to the off-load area b) To resume processing using the automation line, follow Step (i) above and select "Online" from the dropdown menu. 2) As an alternative to pausing automation line operation, racks can be loaded onto the SPU of any stand-alone instrument (if available). - Interpret results in light of the total clinical presentation of the patient including: symptoms, clinical history, data from additional tests, and other appropriate information. - Review this letter with your Medical Director to determine if any further actions are warranted, including a review of results previously generated by affected systems. The firm will implement a correction in the next software release. Your service representative will contact you to schedule your software upgrade when available. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. Customers were asked to complete and return the Response Form. Customers with additional questions were encouraged to call:1-800-854-363

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JJE

Quantity affected

2842

Distribution

US: NJ, OH, NY, GA, FL, TN, WI, MI, MS, CA, NC, TX, PA, DC, IN, KY, IL, WA, MN, LA, ND, ID, WV, AK, AL, MA. OUS: Argentina, Australia, Bahrain, Canada, China, Croatia, Czech Republic, Egypt, Germany,

Date initiated

2018-12-05

Date posted

2019-03-30

Location

Brea, CA

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