FDA Device recall Z-0738-2020
STA SYSTEM CONROL N + P (ref. 00678)
- FDA Device
- Class II
- terminated
- Published 2020-01-01
On 2020-01-01 the FDA classified a Class II recall of STA SYSTEM CONROL N + P (ref. 00678) by Diagnostica Stago, citing 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 fac….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0738-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-18 |
| Published | 2020-01-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Diagnostica Stago |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WA, WI |
Product
STA SYSTEM CONROL N + P (ref. 00678)
Reason
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.
Identifiers
| code_info | REF: 00678 Lot Numbers: 253145, 253416, 253655, 254040, 254206, 254401, 254573, 254760 UDIs: (01)03607450006780(11)…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0738-2020%22
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