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U.S. Department of Health and Human Services

Class 2 Device Recall StatSampler

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 Class 2 Device Recall StatSamplersee related information
Date Initiated by FirmJune 20, 2008
Date PostedAugust 23, 2008
Recall Status1 Terminated 3 on May 30, 2012
Recall NumberZ-2234-2008
Recall Event ID 48685
510(K)NumberK896206 
Product Classification Blood Collection Tubes - Product Code JKA
ProductStatSampler 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.
Code Information Lot number: 7296 Expiration Date: 12/09; Lot 8031 Expiration Date: 3/10 
Recalling Firm/
Manufacturer		 StatSpin, Inc., dba Iris Sample Processing
60 Glacier Dr
Westwood MA 02090-1800
For Additional Information ContactKenneth V. Campanale
781-551-0100
Manufacturer Reason
for Recall		EDTA inadvertently mixed with lithium heparin solution contained in capillary tubes.
FDA Determined
Cause 2		Mixed-up of materials/components
ActionIris 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 Commerce171 vials
DistributionWorldwide Distribution --- USA including states of CA, CO, FL, KY, KS, GA, NC, NJ, OR, PA, and countries of Canada, Hong Kong, UK.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JKA
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