Recall Z-1069-2018— Diagnostica Stago, Inc.

Name: FDA recall Z-1069-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-25

Class II · Terminated

Class II FDA medical device recall by Diagnostica Stago, Inc., initiated 2017-10-25, terminated 2020-05-12. It names one FDA 510(k) clearance: K922040. Product: STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) 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%)..

Recalling firm: Diagnostica Stago, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-10-25
Terminated: 2020-05-12
Firm location: Parsippany, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K922040 — NEOPLASTINE CI PLUSAmerican Bioproducts Co.·cleared 1992-06-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT).

Reason for recall

Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).

Data sourced from openFDA. This site is unofficial and independent of the FDA.