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Terminated

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.

FDA Recall Z-2234-2008 · Posted 2008-08-23

Recalling FirmStatSpin, Inc., dba Iris Sample Processing
Recall StatusTerminated
Product CodeJKA
Date Initiated2008-06-20
Date Terminated2012-05-30
Product Quantity171 vials

Reason for Recall

EDTA inadvertently mixed with lithium heparin solution contained in capillary tubes.

Firm 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.

Root Cause

Mixed-up of materials/components

Distribution Pattern

Worldwide Distribution --- USA including states of CA, CO, FL, KY, KS, GA, NC, NJ, OR, PA, and countries of Canada, Hong Kong, UK.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K896206STATSPIN STATSAMPLERStatspin Technologies · 1989-11-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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