MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for 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.
Reported: August 8, 2018 Initiated: May 4, 2018 #Z-2599-2018
Product Description
MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for 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.
Reason for Recall
The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incorrect MIC results for Mxf could be reported.
Details
- Recalling Firm
- Beckman Coulter Inc.
- Units Affected
- 686 boxes
- Distribution
- NJ, TX, IA, PA, FL, NE, OH, NY, CA, MO, OK, LA
- Location
- Brea, CA
Frequently Asked Questions
What product was recalled? ▼
MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for 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.. Recalled by Beckman Coulter Inc.. Units affected: 686 boxes.
Why was this product recalled? ▼
The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incorrect MIC results for Mxf could be reported.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 8, 2018. Severity: Moderate. Recall number: Z-2599-2018.
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