FDA Device recall Z-1068-2018
STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT)
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT) by Diagnostica Stago, citing confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1068-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-25 |
| Published | 2018-03-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Diagnostica Stago |
| Distribution | n/a |
Product
STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).
Reason
Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
Identifiers
| code_info | Lot 251064 (Exp: 09-2018) Lot 251725 (Exp: 02-2019) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1068-2018%22
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