FDA Device recall Z-0737-2020
STA UNICALIBRATOR (ref. 00675)
- FDA Device
- Class II
- terminated
- Published 2020-01-01
On 2020-01-01 the FDA classified a Class II recall of STA UNICALIBRATOR (ref. 00675) 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-0737-2020 |
| 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 UNICALIBRATOR (ref. 00675)
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: 00675 Lot Numbers: 253180, 253964, 254721, 255108 UDIs: (01)13607450006756(11)171231(17)191231(10)253180(241)006…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 |
|---|
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-0737-2020%22
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