Reported May 22, 2013 · Terminated
Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro…
Iris Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Iris Diagnostics · 9172 Eton Ave · Chatsworth, CA · 91311-5805
Is this the product you have?
- Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12
- Product UsageFor in vitro diagnostic use with the iQ200 series
- Lot codes and dates
- Part Number 800-3104. Lot Number 153-12
- Expiration dateJan 2013
- Amount recalled
- 942 boxes
Where it was sold
- Nationwide
Why it was recalled
The firm initiated this recall because complaints from customers reported that the recovery compared to assigned assay values is significantly below specification. This results in the instrument not passing controls and the customer not being able to run patient samples.
This product could cause temporary or reversible health problems — stop using it.
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