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Babson Sample Preparation Device

Babson Diagnostics, Inc. · Model Babson Sample Preparation Device · UDI-DI 00850058457017

JQC

510(k) clearances

593

Adverse events (5 deaths)

Recalls

164

Facilities

Description

The Babson Sample Preparation Device is a class I exempt device that falls within 21 CFR 862.2050, General purpose laboratory equipment labeled or promoted for a specific medical use, in accordance with FDA regulations. It serves as a sample preparation device used to automate the mixing, centrifugation, and refrigeration of capillary blood samples for chemistry and hematology testing. The Babson Sample Preparation Device is not an analyzer and does not produce test results. The Babson Sample Preparation Device is intended for use only with the Becton, Dickinson, and Company’s BD MiniDraw ™ H&H ™ Capillary Blood Collection Tube and BD MiniDraw ™ SST ™ Capillary Blood Collection Tube, which are used to collect capillary blood from the customer’s fingertip; the H&H will be mixed, and the SST will be mixed and centrifuged by the Babson Sample Preparation Device. The device is intended to be able to process up to 60 tubes per day across multiple customers.

Recalls

Date	Firm	Reason
2019-02-06	LW Scientific, Inc.	The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected through the plastic housing, posing a safety hazard to the technician and potentially d
2019-02-06	LW Scientific, Inc.	The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected through the plastic housing, posing a safety hazard to the technician and potentially d
2019-02-06	LW Scientific, Inc.	The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected through the plastic housing, posing a safety hazard to the technician and potentially d
2017-10-20	Terumo BCT, Inc.	The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, are printed with an incorrect lot number, catalog number, and expiry date; the lot
2017-10-20	Terumo BCT, Inc.	The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, are printed with an incorrect lot number, catalog number, and expiry date; the lot
2016-02-05	Beckman Coulter Inc.	A defective rotor yoke on Allegra X-5 allows improper rotor seating on the hub resulting in possible rotor failure if the buckets are loaded in an imbalanced configuration.
2014-12-03	Iris Diagnostics	Iris International is recalling the RTH8 Rotor used in the StatSpin Express 4 Horizontal Centrifuge because the RTH8 rotor may develop cracks with use over time.
2011-07-15	Global Focus Marketing & Develop	Potential for bucket and insert not seated on the rotor to cause the lid to break and buckets to be ejected.
2010-08-18	StatSpin, Inc., dba Iris Sample Processing	Rotors may fail due to wire spokes breaking
2010-01-27	StatSpin, Inc., dba Iris Sample Processing	Centrifuge shield micro-switch failed due to damage, and the unit opened, ejecting pieces.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.