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U.S. Department of Health and Human Services

Class 2 Device Recall CoatACount Direct Androstenedione

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 Class 2 Device Recall CoatACount Direct Androstenedionesee related information
Date Initiated by FirmJune 09, 2014
Date PostedJuly 15, 2014
Recall Status1 Terminated 3 on July 24, 2015
Recall NumberZ-2058-2014
Recall Event ID 68595
510(K)NumberK954755 
Product Classification Androstenedione assay, in vitro diagnostic - Product Code CIZ
ProductCoat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
Code Information Lot No. TKAN1 batch 587 TKAN1 batch 588 TKAN1 batch 589 TKAN1 batch 590 TKAN1 batch 591 TKAN1 batch 592 TKAN1 batch 593 TKAN1 batch 594 TKAN1 batch 595 TKAN1 batch 596 TKAN1 batch 597 TKAN1 batch 598 TKAN1 batch 599 TKAN1 batch 600 
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics Inc.
5736 W 96th St
Los Angeles CA 90045-5544
For Additional Information Contact
310-645-8200
Manufacturer Reason
for Recall		The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.
FDA Determined
Cause 2		Under Investigation by firm
ActionA recall letter dated 6/9/14 was sent to all customers who purchased the Coat-A-Count Direct Androstenedione because the assay is demonstrating a higher frequency of results compared to alternate platforms. The letter informs the customers of the problems identified, risks to health, and actions to be taken. Customers are instructed to complete and return the Field Correction Effectiveness Check attached to the recall letter within 30 days.
Quantity in Commerce1,164 units
DistributionWorldwide Distribution. US nationwide including CA, MI, NC, NE, NY, OH, PA, TX, and VA; Argentina, Austria, Belgium, Bolivia, Canada, Chile, Colombia, Finland, Germany, Great Britain, Greece, India, Ireland, Italy, Japan, Korea, Netherlands, Paraguay, Peru, South Africa, Spain, Sweden, Switzerland, and Uruguay
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 = CIZ
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