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Gram Positive Identification Panel
FDA product code LQL · Class 1 · Microbiology
25
Registered devices
298
Adverse events
7
Recalls
11
510(k) clearances
Devices with this code
MicroScan — Beckman Coulter, Inc.Sensititre — TREK DIAGNOSTIC SYSTEMS LIMITEDMicroScan — Beckman Coulter, Inc.Sensititre GP Panel PLATE DRY CLI GRAM+ ID AUTO — REMEL, INC.MicroScan — Beckman Coulter, Inc.Microbact Staph Fast Blue Reagent — OXOID LIMITEDMicroScan — Beckman Coulter, Inc.MicroScan — Beckman Coulter, Inc.BD Phoenix™ PID — BECTON, DICKINSON AND COMPANYMicroScan — Beckman Coulter, Inc.MicroScan — Beckman Coulter, Inc.BD BBL™ Crystal™ GP Gram-Positive ID System — BECTON, DICKINSON AND COMPANYBD BBL™ Crystal™ ID Systems Gram-Positive Manual Codebook — BECTON, DICKINSON AND COMPANYMicroScan — Beckman Coulter, Inc.MicroScan — Beckman Coulter, Inc.MICROBACT LISTERIA 12L (20 ID'S) — OXOID LIMITEDMicrobact Staph 12S — OXOID LIMITEDMicroScan — Beckman Coulter, Inc.MicroScan — Beckman Coulter, Inc.BD BBL™ Crystal™ ID Systems Rapid Gram-Positive Manual Codebook — BECTON, DICKINSON AND COMPANYVITEK® 2 GP — BIOMERIEUX , INC.MicroScan — Beckman Coulter, Inc.BD BBL™ Crystal™ Rapid Gram-Positive ID System — BECTON, DICKINSON AND COMPANYMicroScan — Beckman Coulter, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-03 | Oxoid Australia Pty Limited | Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to inconclusive |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2018-03-23 | BioMerieux SA | A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA as |
| 2017-10-11 | Biomerieux Inc | Customers have reported, and an internal investigation has confirmed, occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC)R) 70 |
| 2017-08-25 | Biomerieux Inc | Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC(R) 700327(TM) in association with VITEK(R) |
| 2017-04-20 | Biomerieux Inc | The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). |
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