MICroSTREP plus 1 Panel — Class II medical device recall Z-0108-2016
Terminated recall by Beckman Coulter Inc., reported 2015-10-14, distributed nationwide. Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error may
| Recall number | Z-0108-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2015-09-10 |
| Classified | 2015-10-07 |
| Reported by FDA | 2015-10-14 |
| Terminated | 2016-01-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, BS, CA, DE, EC, IT, KR, MX, PE, PL, RO, SA, TH, UY, ZA |
| Reason classes | specification failure |
| Model numbers | B1027-201 |
Product
MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.
Reason for recall
Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the potential for elevated or false resistant results.
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-0108-2016. 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.