Recall Z-0738-2020— Diagnostica Stago, Inc.

Name: FDA recall Z-0738-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-18

Class II · Terminated

Class II FDA medical device recall by Diagnostica Stago, Inc., initiated 2019-11-18, terminated 2023-01-12. It names one FDA 510(k) clearance: K943518. Product: STA SYSTEM CONROL N + P (ref. 00678). Reason: 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..

Recalling firm: Diagnostica Stago, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-11-18
Terminated: 2023-01-12
Firm location: Parsippany, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K943518 — STA SYSTEM CONTROL [N] + [P] KITAmerican Bioproducts Co.·cleared 1995-03-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

STA SYSTEM CONROL N + P (ref. 00678)

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.