Agency classClass IIOur severity:Severe FDA (Devices)·Z-1370-2015·Announced 2015-04-08

BD FACSCalibur Instruments Recalled for Incorrect Circuit Breaker Amperage

BD Biosciences is recalling 72 BD FACSCalibur instruments because some have circuit breakers with incorrect amperage ratings, which may fail to open during over-current situations.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a circuit breaker failure that could lead to electrical hazards or fire, meeting the criteria for a Severe rating.

Plain-English summary

BD Biosciences, Systems & Reagents is recalling 72 units of the BD FACSCalibur instrument, used for in vitro diagnostics. The recall involves specific catalog numbers (342973, 342975, 34976) and is identified by recall number Z-1370-2015.

The recall is due to a defect where the circuit breakers on some of these instruments may have an incorrect rated amperage of 20 amps instead of the required 2 amps. This discrepancy may cause the circuit breaker to fail to open in an over-current situation.

The affected devices were distributed worldwide, including in the United States (Texas, New Jersey, and Oklahoma) and internationally to Hong Kong, Japan, Singapore, and Belgium. Users should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected.

The recalled product

Product: BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.
Manufacturer: BD Biosciences, Systems & Reagents
Category: Medical Device — In Vitro Diagnostics
Hazard: electrical-fault
fire
Affected units: 72

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Serial Nos. E34297300656
E34297300657
E34297300659
E34297300660
E34297300661
E34297300666
E34297300667
E34297300668
E34297300669
E34297300670
E34297300671
E34297300673
E34297300675
E34297300676
E34297300677
E34297300678 E34297502563
E34297502564
E34297502565
E34297502566
E34297502567

Distribution

Distributed in 3 states:

Same manufacturer · BD Biosciences, Systems & Reagents

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Same hazard · electrical fault