Beckman Coulter Recalls MicroScan Pos Breakpoint Combo Panels Due to False Negatives
Beckman Coulter is recalling MicroScan Pos Breakpoint Combo Panels because they may produce falsely negative results for Staphylococcus aureus quality control tests.
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 2/5 (Moderate).
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. The hazard involves a quality control failure leading to false negatives, which is a significant diagnostic error but does not involve direct physical injury, hospitalization, or high-risk pathogen contamination in the product itself.
Plain-English summary
Beckman Coulter Inc. is recalling MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206. The recall involves 715 units total, with 616 units distributed in the United States and the remainder distributed worldwide to countries including Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand, and the United Kingdom.
The recall was initiated because the company confirmed falsely negative results for the Voges-Proskauer (VP) test using the quality control organism Staphylococcus aureus ATCC 29213. The expected result for this test is positive, but the affected panels may display pale-pink, brown, or colorless results, indicating a false negative. These panels are designed for determining antimicrobial agent susceptibility and identification of specific gram-positive cocci and Listeria monocytogenes.
Healthcare facilities and laboratories that have received these panels should stop using them and contact Beckman Coulter for instructions on return or replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci…
- 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)
- 2016-05-06 Part No. B1017-206
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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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