MicroScan B1017-216Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

14 other recalls cover devices cleared under the same FDA submission (K003619, K010418, K020160, K020162, K043545, K050043, K081013, K081182, K123933, K131275, K150039, K152346, K862140, K863776, K870074, K874876, K934323, K945235, K972688, K993102); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 2, 2020Terminated

   Due to a customer report and internal investigation, it was confirmed that a portion of the affected product lot failed quality control (QC) for ATCC E. Faecalis 29212 versus daptomycin and it is a possibility to obtain false elevated MIC for clinical isolates with daptomycin even when quality control results are within specification.

   Z-0720-2021 · Root cause: Process control · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K003619, K010418, K020160, K020162, K043545, K050043, K081013, K081182, K123933, K131275, K150039, K152346, K862140, K863776, K870074, K874876, K934323, K945235, K972688, K993102. One submission often covers many models, so check the product and lot details in each record.

• Z-2599-2018 · May 4, 2018 · Terminated
  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 a
• Z-1530-2015 · Aug 8, 2014 · Terminated
  MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 51, Catalog
• Z-1531-2015 · Aug 8, 2014 · Terminated
  MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 55, Catalog
• Z-1528-2015 · Aug 8, 2014 · Terminated
  MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg Combo 50, Catalog B1017-
• Z-1533-2015 · Aug 8, 2014 · Terminated
  MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg MIC 38, Catalog B1017-41
• Z-1532-2015 · Aug 8, 2014 · Terminated
  MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 61, Catalog
• Z-1534-2015 · Aug 8, 2014 · Terminated
  MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: ESL plus, Catalog B1027-101
• Z-1529-2015 · Aug 8, 2014 · Terminated
  MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/BP Combo 47, Catalog B10
• Z-1522-2015 · May 14, 2014 · Terminated
  MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan Neg Breakpoint 34 Neg panels are designed for use in determining quantitative and /or quali
• Z-1524-2015 · Apr 8, 2014 · Terminated
  MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 MicroScan Pos Combo 33 B1017-211 panels are designed for use in determining quantitative and /or qualitative a
• Z-1497-2012 · Jun 16, 2011 · Terminated
  MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Urine Combo 55; Catalog Number B1017-409. Siemens Healthcare Diagnostics, West Sacramento, CA.
• Z-1499-2012 · Jun 16, 2011 · Terminated
  MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 47, catalog number: B1017-417. Siemens Healthcare Diagnostics, West Sacramento, CA. For us
• Z-1498-2012 · Jun 16, 2011 · Terminated
  MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 34, catalog number: B1017-404. Siemens Healthcare Diagnostics, West Sacramento, CA.
• Z-0541-2009 · Jul 31, 2008 · Terminated
  MicroScan Synergies Plus Negative Panels, 20 panels per box Medical device designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or