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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
StatSpin, Inc., dba Iris Sample Processing
Lot Codes / Batch Numbers
Lot number: 7296 Expiration Date: 12/09, Lot 8031 Expiration Date: 3/10
Products Sold
Lot number: 7296 Expiration Date: 12/09; Lot 8031 Expiration Date: 3/10
StatSpin, Inc., dba Iris Sample Processing is recalling StatSampler 200 uL, Li Heparin (micro blood collector) Ref: SS2H Packed in Catalog Numbers: SS2H (I due to EDTA inadvertently mixed with lithium heparin solution contained in capillary tubes.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
EDTA inadvertently mixed with lithium heparin solution contained in capillary tubes.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO, FL, GA, KS, KY, NJ, NC, OR, PA
Page updated: Jan 10, 2026