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Moderate riskFDA DeviceClass II

Beckman Coulter MicroScan software recalled for possible false results

Beckman Coulter is recalling 158 MicroScan instruments with LabPro V5.03 Panel Update 11 installed. The analyzers contain incorrect algorithms that may affect antimicrobial susceptibility test results, leading to false susceptibility classifications. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Beckman Coulter recalls

What to do

  1. Check whether your instrument has LabPro V5.03 Panel Update 11 installed (UDI 15099590799243 / V5.03 Panel Update 11) on model B1018-280, B1018-283, B1018-284, B1018-440, or B1018-496.
  2. Be aware that antimicrobial susceptibility results from these instruments may be affected.
  3. The notice doesn't specify a remedy; contact Beckman Coulter for instructions.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan WalkAway Instrument - B1018-496 DxM-1096 MicroScan WalkAway Instrument
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 2 products — see all of them.

Details

Units affected
158 instruments
Illnesses reported
None reported
Manufactured in
250 S Kraemer Blvd, Brea, CA, United States
Classification
Class II
Recall number
Z-2888-2026

In the FDA's words

Description
REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan WalkAway Instrument - B1018-496 DxM-1096 MicroScan WalkAway Instrument Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." UDI: 15099590799243/ V5.03 Panel Update 11 Distribution: US Nationwide distribution including in the states of AK, AL, AR, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WI, WV, WY. Affected quantity: 158 instruments
Hazard
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."

2 products in this recall

MicroScan LabPro software recalled for possible incorrect results

Beckman Coulter is recalling two MicroScan LabPro V5.03 Panel Update 11 products, an electronic update (REF D23352) and a DVD kit (REF D23354), for installation on MicroScan instruments such as the autoSCAN-4 and WalkAway-40 plus. The analyzers contain incorrect algorithms that may affect antimicrobial susceptibility test results and lead to false susceptibility classifications. The recall covers products distributed nationwide, including the listed states.

The agency lists each product separately. Check every one you might have.

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