Z-2599-2018 Class II Terminated
FDA device recall Z-2599-2018 was initiated by Beckman Coulter Inc. on May 4, 2018 and is designated Class II. 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. The recall status is terminated (terminated Aug 7, 2020). Affected quantity: 686 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 8, 2018
- Initiation Date
- May 4, 2018
- Termination Date
- Aug 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 686 boxes
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.
Distribution Pattern
NJ, TX, IA, PA, FL, NE, OH, NY, CA, MO, OK, LA
Code Information
Lot 2018-11-03
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2599-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026