Z-1699-2020Class II

STA - Deficient VIII

Name: Z-1699-2020 STA - Deficient VIII
Creator: Diagnostica Stago, Inc.
Published: 2020-03-04
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2020-03-04 / Terminated / root cause: manufacturing process

FDA source

Diagnostica Stago, Inc. began a recall of 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... on 2020-03-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1699-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-04
Posted: 2020-04-10
Terminated: 2021-11-10
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
Product code: GGP Test, Qualitative And Quantitative Factor Deficiency
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
Root cause tag: manufacturing process
FDA 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 [email protected]. 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 in commerce: 3,225 units
Distribution: Nationwide
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1699-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1699-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-22	2020-04-10

Product code GGP

K892859Class IIThe Stago VIII Deficient Plasma KitAmerican Bioproducts Co. / cleared 1989-06-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)