Beckman Coulter Recalls MICroSTREP plus Panels Due to Manufacturing Error
Beckman Coulter is recalling MICroSTREP plus 1 and 2 panels because a manufacturing error may cause antimicrobial degradation, leading to false resistant results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential for false test results rather than a direct physical injury, fitting the criteria for a moderate severity score.
Plain-English summary
Beckman Coulter Inc. is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels. These medical devices 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 is being conducted because a manufacturing error may lead to antimicrobial degradation. This degradation creates the potential for elevated or false resistant results in susceptibility testing.
A total of 438 units are affected, with 433 units distributed in the United States. The products were distributed worldwide, including in the Bahamas, Belgium, Canada, Ecuador, Germany, Italy, Republic of Korea, Mexico, Peru, Poland, Romania, Saudi Arabia, South Africa, Thailand, and Uruguay. Users should contact Beckman Coulter for instructions on how to proceed.
The recalled product
- 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
- Manufacturer
- Beckman Coulter Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 2016-01-30 2016-03-23
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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