Recall Z-0895-2018— Instrumentation Laboratory Co.

Name: FDA recall Z-0895-2018
Creator: U.S. Food and Drug Administration
Published: 2017-08-02

Class II · Terminated

Class II FDA medical device recall by Instrumentation Laboratory Co., initiated 2017-08-02, terminated 2019-03-29. It names one FDA 510(k) clearance: K122584. Product: Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400. Reason: Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality controls and prolonged sample results..

Recalling firm: Instrumentation Laboratory Co.
Classification: Class II
Status: Terminated
Initiated: 2017-08-02
Terminated: 2019-03-29
Firm location: Bedford, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K122584 — HEMOSIL READIPLAS TINInstrumentation Laboratory CO·cleared 2013-03-24

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

Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400

Reason for recall

Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality controls and prolonged sample results.

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