StatSampler 200 uL, Li Heparin (micro blood collector) Ref: SS2H Packed in Catalog Numbers: SS2H (I vial), SS2H-06 (6 ki
FDA device recall Z-2234-2008 · posted 2008-08-23 · Terminated
Recall details
- Recalling firm
- StatSpin, Inc., dba Iris Sample Processing
- Reason for recall
- EDTA inadvertently mixed with lithium heparin solution contained in capillary tubes.
- 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.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- JKA
- Quantity affected
- 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.
- Date initiated
- 2008-06-20
- Date posted
- 2008-08-23
- Date terminated
- 2012-05-30
- Location
- Westwood, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STATSPIN STATSAMPLER (K896206) | Statspin Technologies | 1989-11-22 |