Lower riskMedical device recall · FDA · Published November 18, 2019
Diagnostica Stago STA System Control N+P Recall: Positive Bias in Factor VIII/IX Testing
Diagnostica Stago recalls STA System Control N+P (ref. 00678) due to positive bias in factor VIII/IX testing compared to international standards. Affected lots may cause inaccurate blood test results.
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.
Take action
Contact the company
📍Recalling firmDiagnostica Stago, Inc.5 Century Dr · Parsippany, NJ 07054-4607
“Diagnostica Stago STA System Control N+P Recall: Positive Bias in Factor VIII/IX Testing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66508-diagnostica-stago-sta-system-control-n-p-recall-positive-bias. Based on FDA recall #Z-0738-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0738-2020%22&limit=1).
The FDA announced on 2019-11-18 that Diagnostica Stago, Inc. is recalling STA SYSTEM CONROL N + P (ref. 00678) due to a positive bias in control levels compared to the International Standard for factor VIII or IX. The agency classified this voluntary Class II recall.
How to tell if you have it
Brand: Diagnostica Stago
Product: STA SYSTEM CONROL N + P (ref. 00678)
UPC: 03607450006780
Lot Numbers: 253145, 253416, 253655, 254040, 254206, 254401, 254573, 254760
Units affected: 5,437
The hazard
A positive bias was confirmed to exist 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.
Context
GovInfoNow's records show Diagnostica Stago, Inc. has 12 other recalls on record since 2017-10-25. Other recent recalls of similar products include the Fujirebio Lumipulse pTau 217 Plasma Controls Recall (2025-12-11), the Aniara Diagnostica ZYMUTEST HIA IgG Kit Recall (2026-04-01), and the Siemens Dimension Tacrolimus Flex Reagent Cartridge Recall (2026-05-07).
How to tell if you have this one
Check for lot numbers 253145, 253416, 253655, 254040, 254206, 254401, 254573, or 254760 on the product label. The product reference code is 00678.
Brand
Diagnostica Stago
Product
STA SYSTEM CONROL N + P (ref. 00678)
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
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
Recall number
Product, codes & lots
Quantity
Z-0737-2020
STA UNICALIBRATOR (ref. 00675); REF: 00675 Lot Numbers: 253180, 253964, 254721, 255108 UDIs: (01)13607450006756(11)171231(17)191231(10)253180(241)00675 (01)13607450006756(11)180630(17)200630(10)253964(241)00675 (01)13607450006756(11)181130(17)201130(10)254721(241)00675 (01)13607450006756(11)190228(17)210228(10)255108(241)00675
5,498
Z-0738-2020
STA SYSTEM CONROL N + P (ref. 00678); REF: 00678 Lot Numbers: 253145, 253416, 253655, 254040, 254206, 254401, 254573, 254760 UDIs: (01)03607450006780(11)171130(17)191130(10)253145(241)00678 (01)03607450006780(11)180131(17)200131(10)253416(241)00678 (01)03607450006780(11)180331(17)200331(10)253655(241)00678 (01)03607450006780(11)180630(17)200630(10)254040(241)00678 (01)03607450006780(11)180731(17)200731(10)254206(241)00678 (01)03607450006780(11)180930(17)200930(10)254401(241)00678 (01)03607450006780(11)181031(17)201031(10)254573(241)00678 (01)03607450006780(11)181130(17)201130(10)254760(241)00678
5,437
Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Look for lot numbers 253145, 253416, 253655, 254040, 254206, 254401, 254573, or 254760 on the product label.
Where it went and when
Where it was distributed
Distributed in 41 states and D.C..
Listed by the agency
Not listed
FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 3.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0738-2020 (November 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0738-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.