Food, drugs, devices › Diagnostica Stago, Inc.
Device recall: STA UNICALIBRATOR (ref. 00675)
FDA enforcement event 84402 is a device recall by Diagnostica Stago, Inc. of Parsippany, NJ, initiated 18 Nov 2019 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 12 Jan 2023. Initiation: voluntary: firm initiated. Diagnostica Stago, Inc. has 16 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Diagnostica Stago, Inc., Parsippany, NJ.
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."
Distribution
"US: MA ME VT CT NJ NY PA DC MD VA NC SC GA FL AL TN MS KY OH IN MI IA WI MN SD ND MT IL MO KS LA AR OK TX CO AZ NV CA HI OR WA AK"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0737-2020 | STA UNICALIBRATOR (ref. 00675) | 5,498 | Class II | Terminated | 1 Jan 2020 |
| Z-0738-2020 | STA SYSTEM CONROL N + P (ref. 00678) | 5,437 | Class II | Terminated | 1 Jan 2020 |
Context
Other enforcement events for Diagnostica Stago, Inc.
All 16 events for Diagnostica Stago, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US: MA ME VT CT NJ NY PA DC MD VA NC SC GA FL AL TN MS KY OH IN MI IA WI MN SD ND MT IL MO KS LA AR OK TX CO AZ NV CA HI OR WA AK"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 12 Jan 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.