Panels, Test, Susceptibility, Antimicrobial
Microbiology · 21 CFR 866.1640
Recent MDR events
98 adverse event reports on file
- POS COMBO 29 PANEL TYPEFeb 22, 2017InjuryBeckman Coulter2919016-2017-00003
- POS COMBO 29 PANEL TYPEFeb 7, 2017InjuryBeckman Coulter2919016-2017-00001
- POS COMBO 29 PANEL TYPEFeb 7, 2017InjuryBeckman Coulter2919016-2017-00002
- POS COMBO PANEL TYPE 34Jul 27, 2016MalfunctionBeckman Coulter Inc2919016-2016-00005
- MICROSTREP PLUS1 PANELSep 15, 2015MalfunctionBeckman Coulter2919016-2015-00109
- NEG COMBO 50May 13, 2015MalfunctionBeckman Coulter2919016-2015-00023
- NEG BREAKPOINT COMBO 34Apr 24, 2015MalfunctionBeckman Coulter2919016-2015-00013
- NEG URINE COMBO 33Apr 24, 2015MalfunctionBeckman Coulter2919016-2015-00017
- NEG URINE COMBO 33Apr 24, 2015MalfunctionBeckman Coulter2919016-2015-00018
- NEG URINE COMBO 61Apr 24, 2015MalfunctionBeckman Coulter2919016-2015-00019
Event type breakdown
Recalls
13 recall events for this product code
- Beckman Coulter, Inc.Open, ClassifiedApr 8, 2026
MicroScan Neg Multidrug Resistant MIC 1 REF C32368
Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.
Z-1794-2026 · View FDA record ↗ - Beckman Coulter, Inc.Open, ClassifiedApr 3, 2026
MicroScan Neg MIC 3J REF C54814
Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics
Z-1772-2026 · View FDA record ↗ - Beckman Coulter, Inc.Open, ClassifiedMar 20, 2026
MicroScan Neg MIC 56 REF C42464
Due to the likely presence of contamination in well(s).
Z-1609-2026 · View FDA record ↗ - Beckman Coulter Inc.TerminatedOct 7, 2015
MICroSTREP plus 1 Panel, Part No. B1027-201
Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the potential for elevated or false resistant results.
Z-0108-2016 · View FDA record ↗ - Beckman Coulter Inc.TerminatedOct 7, 2015
MICroSTREP plus 2 Panel, Part No. B1027-202
Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the potential for elevated or false resistant results.
Z-0109-2016 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedJun 8, 2013
Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099),
The product has the potential for false negative or delayed reaction for Arginine (ARG) results. In addition, 42 hour identification panel holds may occur due to a weak ARG reaction.
Z-1525-2013 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedMay 8, 2013
Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels.
Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads with A. agalactiae affecting multiple antimicrobial agents on MicroScan Microbiology Systems.
Z-1272-2013 · View FDA record ↗ - Beckman Coulter Inc.TerminatedUnknown
MicroScan Pos Combo Panel Type 21, Part No. B1017-201
Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213 in a portion of affected lots of MicroScan Pos Combo and MicroScan Pos Breakpoint Combo panels. The expected result is positive.
Z-0558-2016 · View FDA record ↗ - Beckman Coulter Inc.TerminatedUnknown
MicroScan Pos Combo Panel Type 33, Part No. B1017-211
Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213 in a portion of affected lots of MicroScan Pos Combo and MicroScan Pos Breakpoint Combo panels. The expected result is positive.
Z-0559-2016 · View FDA record ↗ - Beckman Coulter Inc.TerminatedUnknown
MicroScan Pos Combo Panel Type 34, Part No. B1017-214
Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213 in a portion of affected lots of MicroScan Pos Combo and MicroScan Pos Breakpoint Combo panels. The expected result is positive.
Z-0560-2016 · View FDA record ↗
Registered firms
187 firms currently registered for this product code
510(k) clearances
50 clearances for this product code
- Beckman Coulter, Inc.Aug 20, 2025
K243804 · MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)
- Beckman Coulter, Inc.Aug 15, 2025
K250036 · MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)
- Beckman Coulter, Inc.Jul 18, 2025
K250084 · MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)
- Beckman Coulter, Inc.Nov 16, 2020
K202343 · MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )
- Beckman Coulter, Inc.Jun 29, 2020
K201423 · MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)
- Beckman Coulter, Inc.Mar 18, 2020
K193536 · MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)
- Beckman Coulter, Inc.Mar 3, 2020
K193358 · MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)
- Beckman Coulter, Inc.Feb 12, 2019
K183127 · MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL)
PMA approvals
2 premarket approvals for this product code