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Recall Observatory FDA recall evidence

Device product

MICroSTREP plus 2 Panel, Part No. B1027-202 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.

Z-0109-2016

September 10, 2015

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 72176
Status
Terminated
Classification
Class II
Quantity
438 units total (433 units in US)
Official record key
device-enforcement:Z-0109-2016

Official wording

Reason: 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.

Code information: 2016-01-30 2016-03-23

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.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    manufacturing error