CLASS II Device recall · Reported 8 Aug 2018 · FDA Enforcement Report

MicroScan Pos Combo Panel Type recalled by Beckman Coulter

Beckman Coulter is recalling MicroScan Pos Combo Panel Type 43, distributed in 12 states. The recall was initiated on 4 May 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 2018-11-03

Quantity recalled686 boxes

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2599-2018
FDA event ID: 80330
Recalling firm: Beckman Coulter, Brea, CA
Classification: Class II
Status: Terminated
Recall initiated: 4 May 2018
FDA classified: 2 Aug 2018
Reported: 8 Aug 2018
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Listeria
Device type: Other Medical Devices

Timeline

4 May 2018	Recall initiated by company
2 Aug 2018	Classified by FDA	+90 days
8 Aug 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incorrect MIC results for Mxf could be reported.

Listeria monocytogenes can grow at refrigerator temperatures. Infection is most dangerous for pregnant women, newborns, older adults and people with weakened immune systems. Symptoms can appear up to 70 days after eating contaminated food.

Product as listed by the FDA

MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.

Where it was distributed

NJ, TX, IA, PA, FL, NE, OH, NY, CA, MO, OK, LA

California Florida Iowa Louisiana Missouri Nebraska New Jersey New York Ohio Oklahoma Pennsylvania Texas

Questions about this recall

Is MicroScan Pos Combo Panel Type 43 recalled?

Yes. Beckman Coulter recalled MicroScan Pos Combo Panel Type 43 on 4 May 2018. The recall is Class II and its status is Terminated. Recall number Z-2599-2018.

Why was it recalled?

The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incorrect MIC results for Mxf could be reported.

Which lots are affected?

Lot 2018-11-03

Where was it sold?

NJ, TX, IA, PA, FL, NE, OH, NY, CA, MO, OK, LA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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