Z-2234-2008

StatSampler 200 uL, Li Heparin (micro blood collector) Ref: SS2H Packed in Catalog Numbers: SS2H (I vial)...

Name: Z-2234-2008 StatSampler 200 uL, Li Heparin (micro blood collector) Ref: SS2H Packed in Catalog Numbers: SS2H (I vial)...
Creator: StatSpin, Inc., dba Iris Sample Processing
Published: 2008-06-20
License: https://open.fda.gov/license/

StatSpin, Inc., dba Iris Sample Processing / initiated 2008-06-20 / Terminated

FDA source

StatSpin, Inc., dba Iris Sample Processing began a recall of 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)... on 2008-06-20. The reason FDA records is "EDTA inadvertently mixed with lithium heparin solution contained in capillary tubes". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2234-2008
Status: Terminated
Initiated: 2008-06-20
Posted: 2008-08-23
Terminated: 2012-05-30
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.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: EDTA inadvertently mixed with lithium heparin solution contained in capillary tubes.
FDA 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 in commerce: 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.
Product codes and lots: Lot number: 7296 Expiration Date: 12/09; Lot 8031 Expiration Date: 3/10

Product code JKA

K896206Class IIStatspin StatsamplerStatspin Technologies / cleared 1989-11-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)