U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
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Urinalysis controls (assayed and unassayed) - Product Code JJW
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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.
조치
The firm initiated the recall on 07/09/12 by sending out a Medical Device Recall notification to customers via e-mail. The recall notification identified the affected product, reason for recall, and instructions on the recall. Customers were to confirm how many sets of unopened or partially opened IRISpec CA/CB that was in their inventory, dispose of the affected product, and provide written confirmation of the product's disposition. The letter also stated that Iris Diagnostics would replace any unused inventory that was returned at no charge to the customer. Contact information for the recall was also provided. The communications also included a fax response sheet for return/replacement.
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 material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.