Recall Z-2264-2020 ยท PJC Newborn Screening Specimen Collection Paper
PerkinElmer Health Sciences, Inc.
PerkinElmer 226 Sample Collection Device
| Date | Dec 19, 2017 |
| Status | Terminated |
| Reason | PerkinElmer 226 Sample Collection Devices Lot Number 40020001 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack. |
| Root cause | Packaging process control |
| Action | PerkinElmer sent an Urgent Medical Device Correction letter dated 12/22/2017 by email to the sole consignee. PerkinElmer requested the consignee quarantine the product and contact Kerry Chunko, PerkinElmer Sr. Quality Manager for further information 864-299-8787. x 104 (Kerry.Chunko@PerkinElmer.com). The firm also requested the consignee inform all those affected by this issue in their organization and to return the recall response form and return it by fax to 864-299-8787 or as a scanned by email to Kerry.Chunko@PerkinElmer.com. |
| Quantity | 164,952 devices |
| Distribution | US distribution in the state of Ohio |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121864 | PERKINELMER 226 SAMPLE COLLECTION DEVICES Perkinelmer, Inc., Mar 12, 2013 |