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Recall Observatory FDA recall evidence

Device product

Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics

Z-2058-2014

June 09, 2014

Class II

Product summary

Firm
Siemens Healthcare Diagnostics Inc.
Event
Event 68595
Status
Terminated
Classification
Class II
Quantity
1,164 units
Official record key
device-enforcement:Z-2058-2014

Official wording

Reason: The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.

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

Distribution pattern: Worldwide 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.