PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium
FDA device recall Z-2756-2017 · posted 2017-07-24 · Terminated
Recall details
- Recalling firm
- PerkinElmer Health Sciences, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- PJC
- Quantity affected
- 99,968 units
- Distribution
- US Distribution to the state of : AL
- Date initiated
- 2017-05-31
- Date posted
- 2017-07-24
- Date terminated
- 2017-07-27
- Location
- Greenville, SC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PERKINELMER 226 SAMPLE COLLECTION DEVICES (K121864) | Perkinelmer, Inc. | 2013-03-12 |