SoftCytogenetics recall: Software Issue
SoftCytogenetics
Why was SoftCytogenetics recalled?
Software is given wrong results going out to HIS on test that had reruns.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Versions: 4.1.11.20, 4.1.12.11 and 4.1.15.6
- Product
- SoftCytogenetics
- Recalling firm
- Soft Computer Consultants, Inc.
- Quantity
- 5
- Distribution
- US Nationwide Distribution in the states of CA, FL, MN and NJ.
- Recall date
- July 28, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)