Device product
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.
Z-0108-2016
Product summary
- Event
- Event 72176
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5138 units total (4,360 units in US)
- Official record key
device-enforcement:Z-0108-2016
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: 2016-01-27 2016-02-27 2016-03-26 2016-04-02 2016-04-14 2016-05-01 2016-05-15 2016-06-12
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
manufacturing error