Beckman Coulter Recalls MICroSTREP plus 1 and 2 Panels for Manufacturing Error
Beckman Coulter is recalling MICroSTREP plus 1 and 2 panels because a manufacturing error may cause antimicrobial degradation and false resistant results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential false resistant results in medical testing, which poses a risk of harm to patient care, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Beckman Coulter Inc. is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels. The recall is due to a manufacturing error that may lead to antimicrobial degradation, creating the potential for elevated or false resistant results in antimicrobial susceptibility testing.
The affected products 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. The recall involves 5,138 units total, with 4,360 units distributed in the United States. Distribution was worldwide, including the US, Bahamas, Belgium, Canada, Ecuador, Germany, Italy, Republic of Korea, Mexico, Peru, Poland, Romania, Saudi Arabia, South Africa, Thailand, and Uruguay.
The agency classifies this as a Class II recall. Users should stop using the affected panels and contact Beckman Coulter for instructions on return or replacement.
The recalled product
- 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…
- Manufacturer
- Beckman Coulter Inc.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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