Recall Z-1372-2021 ยท LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Beckman Coulter Inc.
MicroScan WalkAway-40 plus Reconditioned Instrument
| Date | Sep 4, 2019 |
| Status | Terminated |
| Reason | Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure. |
| Root cause | Process control |
| Action | On 09/04/2019, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter to its customers via electronic and/or first class postal mail informing them that an investigation revealed that some instruments were manufactured with shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure. Customers were also informed that when a reagent is not dispensed, there is the potential for any of the following to occur: -high probability misidentifications and reporting of erroneous results -panel reads are fla |
| Quantity | 6 systems |
| Distribution | U.S.: CO, FL, IL, IN, KY, ME, MI, MS, PA, Puerto Rico, TN, TX, UT, VA and WA O.U.S.: India, Indonesia, Italy, Japan, Philippines, Poland, Russia, South Korea, Taiwan and Yemen. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K911400 | WALKAWAY TM 40 Baxter Healthcare Corp, Nov 19, 1991 |