Recall Z-0108-2016
Beckman Coulter Inc. · initiated September 10, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 2016-01-27 2016-02-27 2016-03-26 2016-04-02 2016-04-14 2016-05-01 2016-05-15 2016-06-12
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.
FDA-determined cause: Equipment maintenance
Action taken
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.
Details
- Recall number
- Z-0108-2016
- Initiated
- September 10, 2015
- Posted by FDA
- October 7, 2015
- Terminated
- January 22, 2016
- Product code
- LTT – Panels, Test, Susceptibility, Antimicrobial
- Quantity
- 5138 units total (4,360 units in US)
- Distribution
- 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.
- Recalling firm
- Beckman Coulter Inc., Brea, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0109-2016 Class II | MICroSTREP plus 2 Panel, Part No. B1027-202 Product Usage: MicroScan MICroSTREP plus…Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error… | 09/10/2015Terminated |