Z-1609-2026Class II

MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in...

Name: Z-1609-2026 MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in...
Creator: Beckman Coulter, Inc.
Published: 2025-07-24
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-07-24 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter, Inc. began a recall of MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or... on 2025-07-24. FDA classified it as Class II and gives the reason as "Due to the likely presence of contamination in well(s)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1609-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-24
Posted: 2026-03-20
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
Product code: LTT Panels, Test, Susceptibility, Antimicrobial
Reason for recall: Due to the likely presence of contamination in well(s).
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: On 07/24/2025, the firm sent via mail/email an "URGENT MEDICAL DEVICE RECALL" Letter to customers informing them that Beckman Coulter has received reports that when testing clinical isolates there was no growth observed in Ceftazidime (Caz) 1, 8 and 16 mg/mL wells; however, growth was observed in the 4 mg/mL well with multiple panels from this lot. Upon further investigation, it was confirmed the growth was Bacillus spp. and not the clinical isolates being tested. Customers are instructed to: -Consider reviewing previous Caz antimicrobial test results from this lot for any spot growth detection (e.g., isolates with no growth in in Caz 1, 8 and 16 mg/mL wells and growth in the 4 mg/mL well or if there is an unusual increase in Caz MIC values). -Discontinue use of MicroScan Neg MIC 56 Lot 2026-01-03 For any questions regarding this notice, contact Customer Technical Support: -From our website: http://www.beckmancoulter.com -By phone: call 800 677-7226 option 1 in the United States. If replacement product is needed: -Complete the attached Replacement Order Form and email to [email protected] or fax to (866) 294-7850 OR -Call Client Services at (800) 526-3821
Quantity in commerce: 685 boxes
Distribution: U.S. Nationwide distribution in the states of CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, and TX.
Product codes and lots: Catalog Number: C42464 UDI-DI code: 15099590731212 Lot Number: 2026-01-03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1609-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1609-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-20

Product code LTT

K202343Class IIMicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )Beckman Coulter, Inc. / cleared 2020-11-16

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)