BD FACSCalibur — Class II medical device recall Z-1370-2015
Terminated recall by BD Biosciences, Systems & Reagents, reported 2015-04-08, distributed in NJ, OK, TX. The circuit breakers on some BD FACSCalibur instruments may have the incorrect rated amperage (20 amps instead
| Recall number | Z-1370-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BD Biosciences, Systems & Reagents, San Jose, CA, United States |
| Recall initiated | 2015-03-06 |
| Classified | 2015-04-02 |
| Reported by FDA | 2015-04-08 |
| Terminated | 2016-04-04 |
| Distributed | NJ, OK, TX |
| Countries outside the US | HK, JP |
| Quantity | 72 devices |
| Serial numbers | E34297300656, E34297300657, E34297300659, E34297300660, E34297300661, E34297300666, E34297300667, E34297300668, E34297300669, E34297300670, E34297300671, E34297300673, E34297300675, E34297300676, E34297300677, E34297300678, E34297502563, E34297502564, E34297502565, E34297502566, E34297502567, E34297502568, E34297502569, E34297502570, E34297502571 and 47 more |
| Model numbers | 342973, 342975, 34976 |
Product
BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.
Reason for recall
The circuit breakers on some BD FACSCalibur instruments may have the incorrect rated amperage (20 amps instead of 2 amps) causing the circuit breaker to fail to open in an over-current situation.
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-1370-2015. 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.