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U.S. Department of Health and Human Services

Class 2 Device Recall STA Owren Koller

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 Class 2 Device Recall STA Owren Kollersee related information
Date Initiated by FirmMay 21, 2025
Date PostedJune 18, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1993-2025
Recall Event ID 96937
Product Classification General purpose reagent - Product Code PPM
ProductSTA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of the STA-R, STA Compact, STA Satellite and ST art families.
Code Information UDI: (01)13607450003601(11)240331(17)260331(10)270902(241)00360. Lot Number: 270902.
FEI Number 2245451
Recalling Firm/
Manufacturer		 Diagnostica Stago, Inc.
5 Century Dr
Parsippany NJ 07054-4607
For Additional Information ContactPhilippe Barroux
1-973-6311200 Ext. 4117
Manufacturer Reason
for Recall		Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
FDA Determined
Cause 2		Under Investigation by firm
ActionDiagnostica Stago, Inc. notified consignees on 05/21/2025 via email. Consignees were instructed to review inventory for any affected units, stop using the affected lot and destroy it, and complete and return the acknowledgement form.
Quantity in Commerce939 US ( 2,810 total worldwide)
DistributionThe affected lot was distributed to customers in various US states in October and November 2024. The lot was also distributed in other countries including Canada. The lot was provided to two Distributors in US Territories: MedPharm Corp (Guam) and Isla Lab Products (Puerto Rico); MedPharm will be notified by Stago's Asia-Pacific business unit in the coming days and is not part of this report.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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