Globe Scientific 51635Recalls & reported problems
Globe Scientific Inc. · Capillary tube, heparinized for Medica Corp. 10x100/box · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840095607575), received between Jan 29, 2026 and Jan 29, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Component” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- Dec 31, 2025Open, Classified
A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.
Z-1370-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Defective Component1
Patient problems
- Arrhythmia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2026Defective Component
GLOBE SCIENTIFIC CUSTOMER MEDICA CORPORATION FOR THE INVOLVED PRODUCT (CAPILLARY TUBE COATED WITH A HEPARIN / SALT FORMULATION) REPORTED THE FOLLOWING TO GLOBE SCIENTIFIC, THE IMPORTER OF THE PRODUCT: MEDICA OBSERVED ELEVATED POTASSIUM MEASUREMENT BIAS BY UP TO 20% WHEN USING THE CAPILLARY TUBES BY GLOBE SCIENTIFIC (ITEM 51635) ON THE MEDICA EASYSTAT ANALYZER. THIS CONDITION APPEARS IN ALL LOTS OF CAPILLARY TUBES SHIPPED TO MEDICA IN 2025 AND MAYBE AS FAR BACK AS 2022. PRELIMINARY INVESTIGATION AT MEDICA INDICATES THAT THIS CONDITION IS CAUSED BY THE COATING INSIDE THE GLASS CAPILLARY TUBE. MEDICA IS THE EXCLUSIVE CUSTOMER GLOBE SCIENTIFIC SELLS THIS SPECIFIC PRODUCT SKU TO IN THE MARKETPLACE BASED ON THE PROPRIETARY NATURE OF THE RECIPE USED FOR THE HEPARIN / SALT FORMULATION INVOLVED WITH THE PRODUCTION OF THE PRODUCT.
Patient problems: Arrhythmia
MAUDE report 24215772 ↗
Other Tube, Collection, Capillary Blood devices
- CardioChek 5700534Henry Schein, Inc. · TUBE, COLLECTION, CAPILLARY BLOOD1 recall0 reports
- SAFE-T-FILL® 06 0007Ram Scientific, Inc · TUBE, COLLECTION, CAPILLARY BLOOD1 recall0 reports
- SAFE-T-FILL® 06 0186Ram Scientific, Inc · TUBE, COLLECTION, CAPILLARY BLOOD1 recall0 reports
- SAFE-T-FILL® 06 0187Ram Scientific, Inc · TUBE, COLLECTION, CAPILLARY BLOOD1 recall0 reports
- SAFE-T-FILL® 06 0005Ram Scientific, Inc · TUBE, COLLECTION, CAPILLARY BLOOD1 recall0 reports
- SAFE-T-FILL® 06 0185Ram Scientific, Inc · TUBE, COLLECTION, CAPILLARY BLOOD1 recall0 reports
- SAFE-T-FILL® 06 0199Ram Scientific, Inc · TUBE, COLLECTION, CAPILLARY BLOOD1 recall0 reports
- SAFE-T-FILL® 06 0009Ram Scientific, Inc · TUBE, COLLECTION, CAPILLARY BLOOD1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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