Beckman Coulter Inc. Recall 87486
Description: MicroScan WalkAway-40 plus Instrument
Beckman Coulter Inc. Recall 87486 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1370-2021 |
| Event ID | 87486 |
| Event Description | MicroScan WalkAway-40 plus Instrument |
| Product Type | Devices |
| 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. |
| Quantity | 16 systems |
| Recall 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. |
| Device Classification | 20210414 |
| Device Code Info | Catalog Number: B1018-283 UDI Code: 1509959065866 Serial Numbers: 34010001 34010002 34010003 34010004 34010005 34010006 34010007 34010008 34010009 34010010 34010011 34010012 34010013 34010014 34010015 34010016 |
| Center Classification Date | 20210407 |
| Recall Initiation Date | 20190904 |
| Recalling Firm | Beckman Coulter Inc. |
| Initial Notification | Letter |
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