Recall Z-1088-2022 ยท LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Beckman Coulter Inc.
MicroScan WalkAway-96 plus Reconditioned Instrument REF B1018-396R
| Date | Oct 21, 2019 |
| Status | Open, Classified |
| Reason | 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 current rating of 10 ampere |
| Root cause | Mixed-up of materials/components |
| Action | During the week of 10/21/2019, Beckman Coulter sent an "URGENT MEDICAL DEVICE RECALL" Letter via e-mail and postal mail informing customers that some WalkAway instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1A (ampere) current rating rather than the correct current rating at 10A. Customers are instructed to: If the component fails and and the WalkAway suffers a power loss, user should: --Contact the Customer Support Center. If in the United States call 1-800-677-7226. If outside the United States, contact their local Beckman Coulter Repr |
| Quantity | 4 systems |
| Distribution | Worldwide distribution - U.S. Nationwide distribution in the states of Alaska, Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, North Carolina |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K911400 | WALKAWAY TM 40 Baxter Healthcare Corp, Nov 19, 1991 |