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Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
FDA product code LRG · Class 2 · Microbiology
105
Registered devices
137
Adverse events
13
Recalls
45
510(k) clearances
Devices with this code
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Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-12 | Remel, Inc | Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard. |
| 2020-12-02 | Beckman Coulter Inc. | 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. Faecali |
| 2019-10-21 | Beckman Coulter Inc. | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct |
| 2019-10-21 | Beckman Coulter Inc. | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct |
| 2019-10-21 | Beckman Coulter Inc. | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct |
| 2019-10-21 | Beckman Coulter Inc. | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct |
| 2019-10-21 | Beckman Coulter Inc. | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct |
| 2019-10-21 | Beckman Coulter Inc. | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct |
| 2019-09-04 | Beckman Coulter Inc. | Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification an |
| 2019-09-04 | Beckman Coulter Inc. | Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification an |
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