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Terminated

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.

FDA Recall Z-0108-2016 · Posted 2015-10-07

Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeLTT
Date Initiated2015-09-10
Date Terminated2016-01-22
Product Quantity5138 units total (4,360 units in US)

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.

Firm Action

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

Distribution Pattern

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, United Sates (including Puerto Rico), and Uruguay.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K091949MICROSCAN MICROSTREP PLUS, MODEL B1027-201Siemens Healthcare Diagnostics · 2010-01-26K062773MICROSCAN MICROSTREP PLUS PANEL, PENICILLINDade Behring, Inc. · 2006-10-13K062927MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/ML)Dade Behring, Inc. · 2006-10-12K020626MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLINDade Microscan, Inc. · 2002-04-26

Official Source

View FDA Recall →

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

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