Sunquest Laboratory : intended for use by professionals recall
Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.
Why was Sunquest Laboratory : intended for use by professionals recalled?
Online calculations may not be performed as expected or may yield results that are different than expected when the calculation module is called from the Online Entry (OEM) application for a subtest whose subcolumn number on the instrument online string is divisible by 10.
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 6.4.0 and later
- Product
- Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.
- Recalling firm
- Sunquest Information Systems, Inc.
- Quantity
- 127 sites
- Distribution
- Nationwide distribution
- Recall date
- October 24, 2012
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)