FDA Recall Database: Class II Recall: MicroScan Neg Multidrug Resistant MIC 1 REF C32368… by Beckman Coulter, Inc.

Key facts

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Beckman Coulter, Inc. and the affected product is described in FDA's record as: MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial (additional items listed in FDA's full record). FDA's stated reason for the recall is: Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.. The recall is tracked under FDA recall number Z-1794-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial (additional items listed in FDA's full record) -- and the recall number Z-1794-2026. If it matches, stop using or distributing it and contact Beckman Coulter, Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

Beckman Coulter, Inc.’s FDA history

Argus HQ has recorded 3 total FDA actions tied to Beckman Coulter, Inc.: 0 warning letters, 3 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What was recalled and why?

Beckman Coulter, Inc. recalled MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial (additional items listed in FDA's full record). FDA's record states the reason for recall as: Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.. The recall is logged under FDA recall number Z-1794-2026 with a Class II classification.

How serious is this recall?

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial (additional items listed in FDA's full record)).

Has Beckman Coulter, Inc. had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 3 total FDA actions tied to Beckman Coulter, Inc., including 3 recalls and 0 warning letters.

Related enforcement actions