FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculation System-D is used to standardize inocula for microdilution antimicrobial susceptibility test.
- Recall number
- Z-1674-2020
- Recalling firm
- Beckman Coulter Inc.
- Product
- Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculation System-D is used to standardize inocula for microdilution antimicrobial susceptibility test.
- Status
- Terminated
- Initiated
- 2019-12-13
- Posted
- 2020-04-06
- Terminated
- 2021-04-30
- Reason
- Due to customer reports it has been determined that the inoculation system contains the incorrect prompt wands. Use of the incorrect wands could result in false -susceptible results, false-resistant results, possible misidentifications, or possible out-of-range Quality Control results.
- Root cause
- Nonconforming Material/Component
- Action
- On 12/13/2019, the firm notified its customers via "Urgent Medical Device Recall" letter informing customers of the recall and its potential to cause false-susceptible results, false-resistant results, possible misidentifications, or possible out-of-range Quality Control results. The notification instructs customers to take the following actions: 1. Discontinue use and discard any remaining inventory of the incorrect wands with lot number 13.LAG.1 that may be found with the Prompt Inoculation System-D lot number 20201103T. 2. The notification letter also instructs customers to share the contents of the letter with lab/medical directors to determine the need to review previous patient and quality control test results. 3. In order to assure you have received the important communication, please respond within 10 days in one of the following ways: - Electronically, if you received this communication via email - Manually, complete and return the enclosed Response Form 4. If you have any questions regarding this notice, please contact the firm's Customer Support Center: - Via our website, http://www.beckmancoulter.com/customersupport/support - Via phone, call 1-800-677-7226 in the US 5. For customers in the US, if you need replacement products: - Complete the attached "Replacement Order Form" and email the form to askbeckman@beckman.com or fax to (866) 294-7850 or Call Client Services at (800) 526-3821
- Quantity
- 3,472 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, MD, MI, MS, NE, NY, NC, ND, OH, OK, PA, SD, TN, TX, UT, WV, WI, WY and countries of Canada, China, Japan, Paraguay.
- Lot, serial or model codes
- Lot number 20201103T, Expiration Date: 11/3/2020
- 510(k) numbers
- ["K820299"]
- PMA numbers
- not on file
- Product code
- LIE
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28