FDAJanuary 2, 2020device
Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A mix-up of autosampler tube positions with a possibility of misidentification of sample results and a risk of operator injury from an exposed aspiration needle.
What to do
FDA enforcement status: Terminated
Brands named
clinical diagnostic solutionsclinicalclinical diagnostic
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAdirectCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-22026-04-30
- FDABioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.2026-04-22
- FDABW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDABARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDABARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDABARD Dynamic Tip Steerable, Product Number 6DYNTP001;2026-04-10
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