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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Diagnostica Stago, Inc.: A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.

Agency Publication Date: December 23, 2019
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Affected Products

Product: STA UNICALIBRATOR (ref. 00675)

REF: 00675 Lot Numbers: 253180, 253964, 254721, 255108 UDIs: (01)13607450006756(11)171231(17)191231(10)253180(241)00675 (01)13607450006756(11)180630(17)200630(10)253964(241)00675 (01)13607450006756(11)181130(17)201130(10)254721(241)00675 (01)13607450006756(11)190228(17)210228(10)255108(241)00675

Lot Numbers:
Numbers
Product: STA SYSTEM CONROL N + P (ref. 00678)

REF: 00678 Lot Numbers: 253145, 253416, 253655, 254040, 254206, 254401, 254573, 254760 UDIs: (01)03607450006780(11)171130(17)191130(10)253145(241)00678 (01)03607450006780(11)180131(17)200131(10)253416(241)00678 (01)03607450006780(11)180331(17)200331(10)253655(241)00678 (01)03607450006780(11)180630(17)200630(10)254040(241)00678 (01)03607450006780(11)180731(17)200731(10)254206(241)00678 (01)03607450006780(11)180930(17)200930(10)254401(241)00678 (01)03607450006780(11)181031(17)201031(10)254573(241)00678 (01)03607450006780(11)181130(17)201130(10)254760(241)00678

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84402
Status: Resolved
Manufacturer: Diagnostica Stago, Inc.
Manufactured In: United States
Units Affected: 2 products (5,498; 5,437)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.