Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection De
FDA device recall Z-0030-2014 · posted 2013-10-18 · Terminated
Recall details
- Recalling firm
- Perkin Elmer Health Sciences, Inc.
- Reason for recall
- Some devices may be contaminated on the back side of the device with glue in the blood application area.
- Action taken
- 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: Rick.Haines@perkinelmer.com. Please contact PerkinElmer Health Sciences Greenville facility Quality Manager for further information 864-299-8787 (ext 104).
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- JKA
- Quantity affected
- 65,984 devices
- Distribution
- US distribution in OH
- Date initiated
- 2013-09-05
- Date posted
- 2013-10-18
- Date terminated
- 2014-07-17
- 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 |