Beckman Coulter MicroScan Pos Combo Panels Recalled for False Negative Results
Beckman Coulter is recalling MicroScan Pos Combo and Breakpoint Combo panels due to falsely negative Voges-Proskauer results with Staphylococcus aureus.
What this means for you
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 involves a medical device that produces false negative results for a specific quality control organism, which poses a risk of harm through misidentification or incorrect susceptibility testing, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Beckman Coulter Inc. is recalling MicroScan Pos Combo Panel Type 34 (Part No. B1017-214) and MicroScan Pos Breakpoint Combo panels. The recall involves 1,324 units total, with 1,215 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 Beckman Coulter confirmed falsely negative results for the Voges-Proskauer (VP) test when using the Quality Control American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213. The expected result for this test is positive, but the affected panels produced pale-pink, brown, or colorless results, indicating a false negative.
These 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, some fastidious aerobic gram-positive cocci, and Listeria monocytogenes. Users of these products should contact Beckman Coulter for further instructions on how to proceed with the recall.
The recalled product
- Product
- MicroScan Pos Combo Panel Type 34, Part No. B1017-214 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, some fastidio
- 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)
- 2016-04-29 2016-05-06 Part No. B1017-214
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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