Recall Z-1310-2022— Haemonetics Corporation

Name: FDA recall Z-1310-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-26

Class II · Terminated

Class II FDA medical device recall by Haemonetics Corporation, initiated 2022-04-26, terminated 2024-03-15. It names one FDA 510(k) clearance: K002177. Product: TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034. Reason: Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to the normal donor reference range, it could lead to misdiagnosis and incorrect treatment or failure to treat..

Recalling firm: Haemonetics Corporation
Classification: Class II
Status: Terminated
Initiated: 2022-04-26
Terminated: 2024-03-15
Firm location: Boston, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K002177 — THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIESHaemoscope Corp.·cleared 2000-09-14

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

TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034

Reason for recall

Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to the normal donor reference range, it could lead to misdiagnosis and incorrect treatment or failure to treat.

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