Z-0738-2020Class II

STA SYSTEM CONROL N + P (ref. 00678)

Name: Z-0738-2020 STA SYSTEM CONROL N + P (ref. 00678)
Creator: Diagnostica Stago, Inc.
Published: 2019-11-18
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2019-11-18 / Terminated / root cause: manufacturing process

FDA source

Diagnostica Stago, Inc. began a recall of STA SYSTEM CONROL N + P (ref. 00678) on 2019-11-18. FDA classified it as Class II and gives the reason 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...". 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-0738-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-18
Posted: 2019-12-23
Terminated: 2023-01-12
Recalling firm: Diagnostica Stago, Inc.
Product: STA SYSTEM CONROL N + P (ref. 00678)
Product code: GGN Plasma, Coagulation Control
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On November 18, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail stating: FIELD SAFETY NOTICE Combined use of the following reagents STA UNICALIBRATOR (ref. 00675) and STA DEFICIENT VIII (ref. 00725) STA DEFICIENT IX (ref. 00724) Dear Customer, You are using the STA Unicalibrator (00675) and STA Deficient VIII (00725) and/or STA Deficient IX (00724) and according to our records, you have ordered and received in your laboratory one or several kits of the STA - Unicalibrator listed in Appendix 1. Following the identification of a defect, please see the information below about the reagents and lots listed in Appendix 1. Description: Following a customer complaint, Stago has investigated and confirmed a positive bias on some STA - Unicalibrator levels. These high levels affect tests using STA - Deficient IX and STA - Deficient VIII reagents. Stago has accordingly reduced the concerned Unicalibrator plasma levels (see new levels on the attached lot-specific barcode sheets). According to our internal testing results, the reduced Unicalibrator plasma levels result in a decrease of Factor VIII and IX results on normal and below-normal patient plasmas. This change has no impact on the classification of hemophiliac patients (type A or B) as severe, moderate or mild. The reassignment of the Unicalibrator plasma levels necessitated a change in the acceptance ranges on the corresponding Quality Control plasmas for Factor VIII and IX parameters with the STA - Deficient VIII and IX reagents. You will find new barcode sheets for each lot of the affected reagents in the attachments. Actions: Upon receipt of this letter, we kindly ask you to: - No longer use the values indicated for STA - Deficient VIII and IX reagents on the barcode sheets in your possession (for the reagents & lots listed in Appendix 1). - Use the new barcode sheets (attached): - For STA - Unicalibrator: Use the analyzer-spec
Quantity in commerce: 5,437
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 codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0738-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0737-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-01	2019-12-23
Z-0738-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-01	2019-12-23

Product code GGN

K943518Class IISta System Control [N] + [P] KitAmerican Bioproducts Co. / cleared 1995-03-21

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)