China NMPA Product Recall - 170-Hydroxyprogesterone Assay Kit (Time-Resolved Fluorescence Assay) AutoDELFIA® Neonatal 17α-OH-progesterone

PerkinElmer Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its 17α-Hydroxyprogesterone Assay Kit (Time-Resolved Fluorescence Assay) (Registration No.: 20153402061). This action, reported to the National Medical Products Administration (NMPA) on May 27, 2017, with a publication date of July 27, 2017, addresses a labeling error on a kit component. The issue involves analytical grade buffer bottles from batch number 653513, which were incorrectly labeled as "Neo hTSH Assay" instead of 17α-hydroxyprogesterone analytical buffer. Despite this mislabeling, all affected bottles correctly contain the intended 17α-hydroxyprogesterone analytical buffer, and the batch number and expiration date are accurate. PerkinElmer emphasized that this error does not impact the kit's performance, usage, or screening results, posing a negligible health hazard and potentially causing only minor delays in reporting results. Under the NMPA's regulatory oversight, the company requires customers to perform specific actions. These include verifying their inventory for the affected kit batch (batch number 654117) and confirming component batch numbers against the kit's QC certificate. Customers are advised that, after batch confirmation, the buffer can be safely used. Additionally, they must record the quantities of affected kits and return a feedback form to PerkinElmer.