Home / Recalls / Diagnostica Stago, Inc. / Z-0737-2020

Z-0737-2020 Class II Terminated

Recalled by Diagnostica Stago, Inc. — Parsippany, NJ

Recall Details

Product Type
Devices
Report Date
January 1, 2020
Initiation Date
November 18, 2019
Termination Date
January 12, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,498

Product Description

STA UNICALIBRATOR (ref. 00675)

Reason for Recall

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.

Distribution Pattern

US: MA ME VT CT NJ NY PA DC MD VA NC SC GA FL AL TN MS KY OH IN MI IA WI MN SD ND MT IL MO KS LA AR OK TX CO AZ NV CA HI OR WA AK

Code Information

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

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  • Z-0205-2026 Class II — Product: STA Liatest D-Di; REF: 00515; (September 12, 2025)
  • Z-2473-2025 Class II — STA Satellite. Product Code: All references. All software versions. The STA S (July 21, 2025)
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  • Z-2475-2025 Class II — STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-X (July 21, 2025)
  • Z-1993-2025 Class II — STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffe (May 21, 2025)
  • Z-1575-2023 Class II — STA R Max fully automatic clinical instrument designed to perform tests on human (March 22, 2023)
  • Z-1576-2023 Class II — STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 586 (March 22, 2023)