Data Foundry

Medical device recalls 2018

MicroScan Pos Combo Panel Type 43 — Class II medical device recall Z-2599-2018

Terminated recall by Beckman Coulter Inc., reported 2018-08-08, distributed in CA, FL, IA, LA, MO, NE, NJ, NY…. The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incorrect MIC resu

Recall numberZ-2599-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBeckman Coulter Inc., Brea, CA, United States
Recall initiated2018-05-04
Classified2018-08-02
Reported by FDA2018-08-08
Terminated2020-08-07
DistributedCA, FL, IA, LA, MO, NE, NJ, NY, OH, OK, PA, TX
Quantity686 boxes
Model numbersB1017-217FOR

Product

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2599-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.