Beckman Coulter MicroScan Pos Combo Panel Recall for False Negatives
Beckman Coulter is recalling MicroScan Pos 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 may produce inaccurate diagnostic results (false negatives), which poses a risk of harm to patients through potential misdiagnosis or inappropriate treatment, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Beckman Coulter Inc. is recalling MicroScan Pos Combo Panel Type 21 (Part No. B1017-201) and MicroScan Pos Breakpoint Combo panels. The recall is due to confirmed falsely negative results for Voges-Proskauer (VP) tests using the Quality Control American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213. The expected result for this test is positive.
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. The affected lots were distributed worldwide, including nationwide in the United States and in 23 other countries.
Healthcare facilities and laboratories using these panels should stop using the affected lots and contact Beckman Coulter for further instructions. This recall addresses a specific quality control failure that may affect the accuracy of susceptibility testing results.
The recalled product
- Product
- MicroScan Pos Combo Panel Type 21, Part No. B1017-201 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)
- 2016-05-05 Part No. B1017-201
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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