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.
This recall has been terminated (originally issued August 23, 2008).
- Recall Initiated
- June 20, 2008
- Posted
- August 23, 2008
- Terminated
- May 30, 2012
- Recall Number
- Z-2234-2008
- Quantity
- 171 vials
- Firm Location
- Westwood, MA
- Official Source
- View on FDA website ↗
Reason for Recall
EDTA inadvertently mixed with lithium heparin solution contained in capillary tubes.
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 / Code Info
Lot number: 7296 Expiration Date: 12/09; Lot 8031 Expiration Date: 3/10
Root Cause
Mixed-up of materials/components
Action Taken
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.