Recall – Lab automated staining instrument with unintended movement and speed

Company: Biocare Medical, LLC
Date of Enforcement Report: 4/7/2021
Class II

PRODUCT

BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: ” Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1

Recall Number: Z-1333-2021

REASON

Their is a potential that the automated staining instrument with software version 3.5.3.1 may move with random speeds in random direction across its range of motion. This could result in the instrument hitting end stops or running into other components on the working deck. This could also result in wash buffer being dispensed on random locations.

RECALLING FIRM/MANUFACTURER

Biocare Medical, LLC on 2/25/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

72 units

DISTRIBUTION

U.S. Nationwide and International

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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