Z-1674-2020Class II

Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 -

Name: Z-1674-2020 Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 -
Creator: Beckman Coulter Inc.
Published: 2019-12-13
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2019-12-13 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculation System-D is used... on 2019-12-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1674-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-13
Posted: 2020-04-06
Terminated: 2021-04-30
Recalling firm: Siemens Healthcare Diagnostics 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.
Product code: LIE Reagent/Device, Inoculum Calibration
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected] or fax to (866) 294-7850 or Call Client Services at (800) 526-3821
Quantity in commerce: 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.
Product codes and lots: Lot number 20201103T, Expiration Date: 11/3/2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1674-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1674-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-06

Product code LIE

K820299Class IIPrompt Inoculation System3M Company / cleared 1982-03-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)