AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow

FDA device recall Z-0648-2017 · posted 2016-11-21 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

Beckman Coulter is recalling the AQUIOS Lyse Reagent Kit because it may lead to an increased generation of notifications and flags when used on the AQUIOS CL when running the AQUIOS Tetra application. The issue could lead to an increase in the number of samples requiring review and re-runs with a potential delay to the reporting of results. Depending on the specimen age, a new blood specimen may be required.

Action taken

Beckman Coulter sent an Urgent Medical Device Recall letter dated October 19, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions regarding the notice are instructed to contact our Customer Support Center http://www.beckmancoulter.com/customersupport/support; 1-800-369-0333 in the US and Canada; outside the US and Canada contact local Beckman Coulter Representative.

Root cause

Under Investigation by firm

Status

Terminated

Product code

OYE

Quantity affected

2367 units total (207 units in US)

Distribution

Worldwide Distribution - US Nationwide and the countries of Belgium, Botswana, Canada, Chile, Columbia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Italy, Malaysia, Netherlands, Poland,

Date initiated

2016-10-19

Date posted

2016-11-21

Date terminated

2017-02-24

Location

Brea, CA

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