Diagnostica Stago, Inc.: 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

Recall number

Z-1699-2020

Recalling firm

Diagnostica Stago, Inc.

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

Status

Terminated

Initiated

2020-03-04

Posted

not on file

Terminated

2021-11-10

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

Root cause

Nonconforming Material/Component

Action

Stago notified on 3/4/20 end users of the risks to factor VIII tests in writing. Letters issued via email, US mail, and/or UPS overnight mail. Letter states reason for recall, health risk and action to take: To remove this cross-contamination risk, a special pre-wash has been developed for the concerned Stago methodology. It involves special washing of needle 1 before every factor VIII assay in order to eliminate any residual quantities of Emicizumab. This cleaning sequence has been implemented in the stated available software versions. Customers not possessing these software levels will be upgraded by Stago Field Support personnel. Completed enclosed acknowledgement coupon to Stago confirming you have read the letter and will apply the instructions Please fax to 1-973-644-9348 or e-mail toquality.systems@us.stago.com. For additional information, please contact your Stago Hotline at 1-800-725-0607. In addition- Since the Stago analyzer platforms are open systems, analyzer customers may be performing other factor VIII assays (e.g. LDTs, or other manufacturers factor VIII products) that Stago has no visibility to, or control over. Therefore an Information Letter issued to all other US customers of the analyzers, to alert customers to the risk that factor VIII testing on these Stago analyzers can be affected by the Emicizumab molecule, and to contact technical service teams for assistance.

Quantity

3,225 units

Distribution

Nationwide

Lot, serial or model codes

All lots  This cleaning sequence has been implemented in the following available software versions. Customers not possessing these software levels will be upgraded by Stago Field Support personnel:    STA-R¿ Max (all serial numbers):   Software version 4.05.04 or higher, and  Methodology Update (MU) to enhance database version MS215.   STA-R¿ Evolution (serial numbers higher than 8012756):  Software version 3.04.09 or higher  STA¿ Compact Max (all serial numbers):   Software version 110.05 or higher.

510(k) numbers

["K892859"]

PMA numbers

not on file

Product code

GGP

Firm FEI

2245451

Firm city

Parsippany

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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