Recall Z-0030-2014 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Perkin Elmer Health Sciences, Inc.
Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
| Date | Oct 18, 2013 (initiated Sep 5, 2013) |
| Status | Terminated |
| Reason | Some devices may be contaminated on the back side of the device with glue in the blood application area. |
| Root cause | Material/Component Contamination |
| Action | The firm, Perkin Elmer, sent an "URGENT - MEDICAL DEVICE RECALL" letter dated September 5, 2013 via email to its consignees. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately notify all submitting facilities and personnel that have received the PerkinElmer 226 Sample Collection Device of the potential glue contamination and to distribute the enclosed record of actions form to all submitting facilities/personnel and encourage them to perform the inspection activities as listed in the letter; and complete and return the enclosed Reca |
| Quantity | 65,984 devices |
| Distribution | US distribution in OH |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121864 | PERKINELMER 226 SAMPLE COLLECTION DEVICES Perkinelmer, Inc., Mar 12, 2013 |