Abbott Laboratories has just informed us about a product recall of their Intact PTH Assay on the ARCHITECT. The manufacturer’s investigation has demonstrated that the Intact PTH Assay results were falsely elevated on average by 13-40%. Therefore, since we were using the defective reagent lots identified, we are immediately discontinuing this assay and will be sending the samples out to Quest Diagnostics, which uses an alternate method, but has similar reference ranges to the current method.
Please review your recent records on your patients for the Intact PTH assay and determine if retesting of the Intact PTH is needed. Also, please note that the TCH Laboratory was performing the test every day from Monday-Friday, but due to the send out, the turnaround time will be from 3-5 days. We apologize for any inconvenience this may cause in patient management.Please feel free to contact Dr. Devaraj, 832-826-1717, if you have more questions