Babson Sample Preparation DeviceRecalls & reported problems
Babson Diagnostics, Inc. · 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. · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850058457017), received between Apr 28, 2026 and Apr 28, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2026Use of Device Problem
ON (B)(6) 2026, CUSTOMER'S SAMPLE WAS NOT PROCESSED BY THE BABSON SAMPLE PREPARATION DEVICE (SPD) ON ORDER (B)(4) (SAMPLE ID (B)(6)). THIS WAS DISCOVERED WHEN A BABSON SERVICE TEAM MEMBER VISITED THE COLLECTION SITE ON (B)(6) 2026. HE FOUND A GOLD SAMPLE TUBE, CONTAINING THE CUSTOMER'S BLOOD, IN THE CADDY PORTION OF THE SPD. THE SAMPLE SAT IN THE CADDY OVERNIGHT AND HAD NOT BEEN PROCESSED. THE SERVICE TEAM MEMBER WAS ABLE TO REBOOT THE SPD WHICH RESTORED THE DEVICE TO PROPER FUNCTIONALITY. THE CUSTOMER'S SAMPLE WAS BROUGHT BACK TO THE LABORATORY; HOWEVER, THE SAMPLE WAS DEEMED UNVIABLE AND COULD NOT BE PROCESSED. THE CUSTOMER WAS NOTIFIED OF HUMAN CHORIONIC GONADOTROPIN (HCG) PREGNANCY TEST NOT PERFORMED ON (B)(6) 2026 BY A BETTERWAY CUSTOMER SERVICE REPRESENTATIVE. THE CUSTOMER WAS OFFERED A RECOLLECTION, WHICH THE CUSTOMER ACCEPTED. ON THE SAME DAY (B)(6) 2026, THEIR NEW SAMPLE (ORDER (B)(4), SAMPLE ID (B)(6)) WAS SUCCESSFULLY COLLECTED. THE HCG PREGNANCY TEST RESULT WAS REPORTED TO THE CUSTOMER ON (B)(6) 2026. NO CRITICAL LAB TEST VALUES WERE DETECTED. CUSTOMER DID NOT REPORT SERIOUS INJURY, ILLNESS, OR DELAY IN DIAGNOSIS. UPON FURTHER INVESTIGATION, IT WAS DISCOVERED THAT THE I
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25017224 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.