Recall Z-1699-2020— Diagnostica Stago, Inc.

Name: FDA recall Z-1699-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-04

Class II · Terminated

Class II FDA medical device recall by Diagnostica Stago, Inc., initiated 2020-03-04, terminated 2021-11-10. It names one FDA 510(k) clearance: K892859. Product: STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in tests for the determination of factor VIII activity in plasma on STA-R and STA Compact analyzer platforms as follows: (A) STA-R Max, Product Codes: 58989, 58990 (B) STA-R Evolution, Product Codes: 58986, 58987, 58988 (C) STA Compact Max, Product Codes: 59026, 59027 (D) STA Compact, Product Codes: 58978, 58979. Reason: A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago instruments, clotting times will be shortened that may cause factor VIII levels reported to be falsely increased.

Recalling firm: Diagnostica Stago, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-03-04
Terminated: 2021-11-10
Firm location: Parsippany, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K892859 — THE STAGO VIII DEFICIENT PLASMA KITAmerican Bioproducts Co.·cleared 1989-06-23

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 - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in tests for the determination of factor VIII activity in plasma on STA-R and STA Compact analyzer platforms as follows: (A) STA-R Max, Product Codes: 58989, 58990 (B) STA-R Evolution, Product Codes: 58986, 58987, 58988 (C) STA Compact Max, Product Codes: 59026, 59027 (D) STA Compact, Product Codes: 58978, 58979

Reason for recall

A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago instruments, clotting times will be shortened that may cause factor VIII levels reported to be falsely increased

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