CardioChek 5700534Recalls & reported problems
Henry Schein, Inc. · CardioChek Plus Analyzer Starter Pack · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Dec 2, 2019Terminated
One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.
Z-0834-2020 · Root cause: Device Design · FDA record ↗
Other TUBE, COLLECTION, CAPILLARY BLOOD devices
- Globe Scientific 51635Globe Scientific Inc. · Tube, Collection, Capillary Blood1 recall1 report
- 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 0009Ram Scientific, 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 0199Ram 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 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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