Z-1370-2015Class II

BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use

Name: Z-1370-2015 BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use
Creator: BD Biosciences, Systems & Reagents
Published: 2015-03-06
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2015-03-06 / Terminated

FDA source

BD Biosciences, Systems & Reagents began a recall of BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use on 2015-03-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1370-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-06
Posted: 2015-06-26
Terminated: 2016-04-04
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.
Product code: OYE Flow Cytometric Reagents And Accessories.
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.
FDA root cause: Mixed-up of materials/components
Action: BD Biosciences sent an Important Product Recall letter on March 6, 2015 by certified mail and Field Change Notification (FCN FCB15-01-660312 directing Field Service Engineers to correct the circuit breaker is in process. Customers with questions were instruct to contact BD Customer Support at 1-877-232-8995 (prompt 2) in the United States. For customers outside the US were instructed to contact their local BD Biosciences representative or distributor. For questions regarding this recall call 408-954-6080.
Quantity in commerce: 72 devices
Distribution: Worldwide Distribution -US including TX, NJ, and OK and Internationally to Hong Kong, Japan, Singopore, and Belguim
Product codes and lots: Serial Nos. 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, E34297502572, E34297502573, E34297502574, E34297502575, E34297502576, E34297502577, E34297502578, E34297502579, E34297502580, E34297502581, E34297502583, E34297502584, E34297502585, E34297502586, E34297502587, E34297502588, E34297502589, E34297502590, E34297502591, E34297502592, E34297502593, E34297502594, E34297502595, E34297502596, E34297502597, E34297502599, E34297502600, E34297502601, E34297502602, E34297502603, E34297502604, E34297502605, E34297502606, E34297502607, E34297502608, E34297502612, E34297502613, E34297502619, E34297502620, E34297502621, E34297502629, E34297600499, E34297600501, E34297600502, E34297600503, E34297600507, E34297600508.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1370-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1370-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-04-02

Product code OYE

K980858Class IIMultitest Cd3/cd16+56/cd45/cd19 Reagent and Multitest Imk Kit Lysing SolutionBecton Dickinson Immunocytometry Systems / cleared 1998-05-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)