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Biocare Medical, LLC FDA Recalls
2 recalls on file across devices, 0 of them Class I and 1 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE PClass IISep 25, 2024Kits containing the DAB chromogen buffer, intended for use i |
| BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containClass IIFeb 25, 2021Their is a potential that the automated staining instrument |