ClearanceBrief
Recall Z-0108-2016 ยท LTT Panels, Test, Susceptibility, Antimicrobial

Beckman Coulter Inc.

MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.

DateOct 7, 2015 (initiated Sep 10, 2015)
StatusTerminated
ReasonBeckman 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.
Root causeEquipment maintenance
ActionBeckman 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.
Quantity5138 units total (4,360 units in US)
DistributionWorldwide 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, United Sates (including Puerto Rico), and Uruguay.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K020626MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN
Dade Microscan, Inc., Apr 26, 2002
K062773MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN
Dade Behring, Inc., Oct 13, 2006
K062927MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/ML)
Dade Behring, Inc., Oct 12, 2006
K091949MICROSCAN MICROSTREP PLUS, MODEL B1027-201
Siemens Healthcare Diagnostics, Jan 26, 2010