Recalls / —
—#140097
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.
- FDA product code
- LTT — Panels, Test, Susceptibility, Antimicrobial
- Device class
- Class 2
- Medical specialty
- Microbiology
- 510(k) numbers
- K020626, K062773, K062927, K091949
- Affected lot / code info
- 2016-01-30 2016-03-23
Why it was recalled
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.
Root cause (FDA determination)
Equipment maintenance
Action the firm took
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.
Recalling firm
- Firm
- Beckman Coulter Inc.
- Address
- 250 S Kraemer Blvd, Brea, California 92821-6232
Distribution
- 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.
Timeline
- Recall initiated
- 2015-09-10
- Posted by FDA
- 2015-10-07
- Terminated
- 2016-01-22
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #140097. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.