Reported Aug 8, 2012 · Terminated
IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec …
Iris Diagnostics
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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?
- IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074
- Intended UseIRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only
- Lot codes and dates
Iris Diagnostics part number 800-0074lot number 131-12
- Amount recalled
- 862
Where it was sold
- Nationwide
Why it was recalled
The firm recalled after it received complaints of IRISpec CA/CB two part Urine Chemistry Control, 101131-12, where the nitrite results read negative for the part B control, which should be positive.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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