Drug recall
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for…
FDA recall event 70893 · Class II · Beckman Coulter, Inc.
Key facts
| Event ID | 70893 |
|---|---|
| Recall numbers | Z-1528-2015, Z-1529-2015, Z-1530-2015, Z-1531-2015, Z-1532-2015, Z-1533-2015, Z-1534-2015 |
| Recalling firm | Beckman Coulter, Inc. |
| Product type | Devices |
| Products | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: ES¿L plus, Catalog B1027-101 Microbiology: For…, MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/BP Combo 47, Catalog B1017-417 Microbiology…, MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg Combo 50, Catalog B1017-406 Microbiology…, MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg MIC 38, Catalog B1017-412 Microbiology: For…, MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 51, Catalog B1017-407… and 2 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria. |
| Initiation date | Aug 8, 2014 |
| Report date | May 6, 2015 |
| Termination date | Apr 27, 2015 |
| City | West Sacramento |
| State | CA |
| Country | United States |
| FEI number | 2919016 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: