Recall Z-2994-2018— Diagnostica Stago, Inc.

Name: FDA recall Z-2994-2018
Creator: U.S. Food and Drug Administration
Published: 2018-07-24

Class II · Terminated

Class II FDA medical device recall by Diagnostica Stago, Inc., initiated 2018-07-24, terminated 2020-05-18. It names one FDA 510(k) clearance: K922565. Product: Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. REF: 00666 The STA¿ - N¿oplastine¿ CI kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿, STA Compact¿ and STA Satellite¿. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).. Reason: QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %).

Recalling firm: Diagnostica Stago, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-07-24
Terminated: 2020-05-18
Firm location: Parsippany, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K922565 — NEOPLASTINE(R) CI KITAmerican Bioproducts Co.·cleared 1992-12-07

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

Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. REF: 00666 The STA¿ - N¿oplastine¿ CI kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿, STA Compact¿ and STA Satellite¿. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).

Reason for recall

QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)

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