Recall Z-2756-2017— PerkinElmer Health Sciences, Inc.
Class III · Terminated
Class III FDA medical device recall by PerkinElmer Health Sciences, Inc., initiated 2017-05-31, terminated 2017-07-27. It names one FDA 510(k) clearance: K121864. Product: PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.. Reason: PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack..
- Recalling firm
- PerkinElmer Health Sciences, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2017-05-31
- Terminated
- 2017-07-27
- Firm location
- Greenville, SC, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.
Reason for recall
PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack.
Data sourced from openFDA. This site is unofficial and independent of the FDA.