MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels… — Class II medical device recall Z-1529-2015
Terminated recall by Beckman Coulter, Inc., reported 2015-05-06, distributed nationwide. Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabili
| Recall number | Z-1529-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., West Sacramento, CA, United States |
| Recall initiated | 2014-08-08 |
| Classified | 2015-04-27 |
| Reported by FDA | 2015-05-06 |
| Terminated | 2015-04-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, BR, BS, CA, CN, DE, EC, EG, ES, LT, MX, PE, PL, PT, PY, RO, SG, TH, TT, TW, UY, VE, ZA |
| Model numbers | B1017-417 |
Product
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: 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 agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1529-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.