Perkin Elmer 226 Sample Collection Device, Serial numbers:… recallZ-0030-2014 · Perkin Elmer Health Sciences, Inc. · initiated Sep 5, 2013
Class II Terminated All recalls posted in October 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Perkin Elmer Health Sciences, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Some devices may be contaminated on the back side of the device with glue in the blood application area.
FDA root cause category: Material/Component Contamination
What the company is doing
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 Recall Response Form return it to PerkinElmer Health Sciences via fax to: 864-299-8797 or email to: [email protected]. Please contact PerkinElmer Health Sciences Greenville facility Quality Manager for further information 864-299-8787 (ext 104).
Recall details
- Recall number
- Z-0030-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 5, 2013
- Posted by the FDA
- Oct 18, 2013
- Recalling firm
- Perkin Elmer Health Sciences, Inc.
- Quantity
- 65,984 devices
- Product code
- JKA
- FDA submissions
- K121864
- Distribution
- US distribution in OH
Product description
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.
Code information (models, lots, serial numbers)
Job number: 313119, Item Lot number: Ohio HEA 2518, Serial numbers: 06132903 - 06198900.
Other devices under the same FDA submission
1 device cleared under K121864 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Revvity 226 Newborn Screening CardRevvity, Inc. · Newborn Screening Specimen Collection Paper1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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