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U.S. Department of Health and Human Services

Class 3 Device Recall STA

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 Class 3 Device Recall STAsee related information
Date Initiated by FirmMarch 30, 2007
Date PostedJuly 03, 2007
Recall Status1 Terminated 3 on November 30, 2009
Recall NumberZ-0979-2007
Recall Event ID 37834
510(K)NumberK922040 
Product Classification in vitro diagnostic - Product Code GJS
ProductSTA Neoplastine CI Plus (10), (cat. 0667). 12 x 10 ml. in vitro diagnostic for the determination of prothrombin time (PT).
Code Information Lot 061781, June 2008
Recalling Firm/
Manufacturer		 Diagnostica Stago, Inc.
5 Century Dr
Parsippany NJ 07054-4607
For Additional Information ContactMelissa Cole
800-222-2624 Ext. 4416
Manufacturer Reason
for Recall		Based on the confirmed clotting times in the upper part of the assigned ranges of STA-Coag Control ABN control plasmas when used with STA-Neoplastine CI Plus, use of this lot may cause difficulty during the validation of the STA-Coag Control ABN.
FDA Determined
Cause 2		Other
ActionRecall notification letters were sent on March 30, 2007 by first class mail. The letter advises customers that lot 061781 of STA-Neoplastine Cl Plus may cause difficulty during the vailidation process of STA-Coag Control ABN control plasmas, and asks that the lot number be discontinued.
Quantity in Commerce170 units
DistributionNationwide.
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 = GJS
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