Recall Z-2234-2008 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
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.
| Date | Aug 23, 2008 (initiated Jun 20, 2008) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K896206 | STATSPIN STATSAMPLER Statspin Technologies, Nov 22, 1989 |