IRISpec" CA/CB two-part urine chemistry control twin recall
IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC…
Why was IRISpec" CA/CB two-part urine chemistry control twin 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.
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?
Iris Diagnostics part number 800-0074, lot number 131-12.
- Product
- IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC…
- Recalling firm
- Iris Diagnostics
- Quantity
- 862
- Distribution
- Nationwide Distribution
- Recall date
- August 8, 2012
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)