FDA Medical Device Recalls (openFDA)
StatSpin, Inc., dba Iris Sample Processing: StatSampler 200 uL, Li Heparin (micro blood collector) Ref: SS2H Packed in Catalog Numbers: SS2H (I vial), SS2H-06 (6 kits/case), CH2C-I0 (I0 vials/kit) Intended for collection and processing of capillary blood to prepare plasma/serum.
- Recall number
- Z-2234-2008
- Recalling firm
- StatSpin, Inc., dba Iris Sample Processing
- Product
- StatSampler 200 uL, Li Heparin (micro blood collector) Ref: SS2H Packed in Catalog Numbers: SS2H (I vial), SS2H-06 (6 kits/case), CH2C-I0 (I0 vials/kit) Intended for collection and processing of capillary blood to prepare plasma/serum.
- Status
- Terminated
- Initiated
- 2008-06-20
- Posted
- 2008-08-23
- Terminated
- 2012-05-30
- Reason
- EDTA inadvertently mixed with lithium heparin solution contained in capillary tubes.
- Root cause
- Mixed-up of materials/components
- Action
- Iris Sample Processing notified customers by telephone followed by an Urgent: Product Recall letter dated 6/19/08. Users are requested to return inventory, to not use product from Lot Number 7296, and to repeat tests where the recalled tubes were used. The firm identified an additional lot : 8031 was effected and recalled the lot to two consignees.
- Quantity
- 171 vials
- Distribution
- Worldwide Distribution --- USA including states of CA, CO, FL, KY, KS, GA, NC, NJ, OR, PA, and countries of Canada, Hong Kong, UK.
- Lot, serial or model codes
- Lot number: 7296 Expiration Date: 12/09; Lot 8031 Expiration Date: 3/10
- 510(k) numbers
- ["K896206"]
- PMA numbers
- not on file
- Product code
- JKA
- Firm FEI
- 1221015
- Firm city
- Westwood
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28