SoftLab Software Laboratory information system to be recall
SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,
Why was SoftLab Software Laboratory information system to be recalled?
Display of lab results based on incorrect LOINC code/test descriptions for tests that were performed at a reference lab, saved incorrectly, and sent to systems that display the EMR.
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 4.5.4.3, 4.5.4.5, 4.5.4.6, 4.5.4.8, 4.5.4.9, 4.5.4.20, 4.5.4.30, 4.5.4.40, 4.5.5.0, 4.5.5.10, and 4.5.5.20
- Product
- SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,
- Recalling firm
- Soft Computer Consultants, Inc.
- Quantity
- 18 units
- Distribution
- US Distribution to states of: CA, IL, LA, MA, MD, MI, MN, NJ, NY, PA, and TX.
- Recall date
- August 9, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)