CLASS II Device recall · Reported 22 Apr 2020 · FDA Enforcement Report
STA - Deficient VIII, Product recalled by Diagnostica Stago
Diagnostica Stago is recalling STA - Deficient VIII, distributed nationwide in the US. The recall was initiated on 4 Mar 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1699-2020
- FDA event ID
- 85167
- Recalling firm
- Diagnostica Stago, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Mar 2020
- FDA classified
- 10 Apr 2020
- Reported
- 22 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 4 Mar 2020 | Recall initiated by company | |
| 10 Apr 2020 | Classified by FDA | +37 days |
| 22 Apr 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
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
Which lots are affected?
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.
Where was it sold?
Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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