Z-2756-2017Class III

PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used...

Name: Z-2756-2017 PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used...
Creator: PerkinElmer Health Sciences, Inc.
Published: 2017-05-31
License: https://open.fda.gov/license/

Revvity Health Sciences, Inc. / initiated 2017-05-31 / Terminated / root cause: packaging

FDA source

PerkinElmer Health Sciences, Inc. began a recall of 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... on 2017-05-31. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2756-2017
Classification: Class III
Status: Terminated
Initiated: 2017-05-31
Posted: 2017-07-24
Terminated: 2017-07-27
Recalling firm: Revvity Health Sciences, Inc.
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.
Product code: PJC Newborn Screening Specimen Collection Paper
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.
Root cause tag: packaging
FDA root cause: Packaging
Action: PerkinElmer sent an Urgent Medical Device Correction letter dated May 30, 2017, to the sole consignee. PerkinElmer requested the consignee implement the following actions: 1. Discontinue use of the pack label to track the device serial numbers distributed to your sample submitters. 2. Verify submitter of devices received without provider information prior to demographic entry. 3. Verify the serial number of the pack label matches the device serial numbers within the pack of your undistributed inventory prior to distributing to your sample submitter or, 4. Return undistributed inventory to PerkinElmer for inspection , and rework if required. For further questions please call (864) 299-8787.
Quantity in commerce: 99,968 units
Distribution: US Distribution to the state of : AL
Product codes and lots: lot numbers 317113 and 317114

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2756-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2756-2017	Class III	Terminated	Voluntary: Firm initiated	2017-08-02	2017-07-24

Product code PJC

K121864Class IIPerkinelmer 226 Sample Collection DevicesPerkinelmer, Inc. / cleared 2013-03-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)