MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICroSTREP plus panels are designed for use in dete

FDA device recall Z-0108-2016 · posted 2015-10-07 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the potential for elevated or false resistant results.

Action taken

Beckman Coulter Inc. sent an Urgent Medical Device Recall letter dated Setember 10, 2015 to all customers who purchased the MICroSTREP plus 1 and MICroSTREP plus 2. The letter identified the affected products, problem and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions regarding the notice, are instructed to contact their Customer Support Representative:website: http://www.beckmancoulter.com or by phone: 1-800-677-7226 in the United States and Canada.

Root cause

Equipment maintenance

Status

Terminated

Product code

LTT

Quantity affected

5138 units total (4,360 units in US)

Distribution

Worldwide Distribution - US Nationwide and the countries of Bahamas, Belgium, Canada, Ecuador, Germany, Italy, Republic of Korea, Mexico, Peru, Poland, Romania, Saudi Arabia, South Africa, Thailand, U

Date initiated

2015-09-10

Date posted

2015-10-07

Date terminated

2016-01-22

Location

Brea, CA

Related 510(k) clearances