Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400

FDA device recall Z-0895-2018 · posted 2018-03-03 · Terminated

Recall details

Recalling firm: Instrumentation Laboratory Co.
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.
Action taken: On August 2, 2017, Instrumentation Laboratory sent an Urgent Medical Device Removal letters dated August 2, 2017 to their customers. On October 5, 2017 Instrumentation Laboratory expanded their recall adding 3 additional lots to a second Urgent Medical Device Removal letter. On February 26, 2018, Instrumentation Laboratory expanded their recall a 3rd time to include 1 additional lot to a third Urgent Medical Device Removal letter. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete a Mandatory Tracking Response form. For questions contact your Customer Service Representative at 1-800-955-9525, option #1.
Root cause: Under Investigation by firm
Status: Terminated
Product code: GJS
Quantity affected: 14,894 kits
Distribution: Worldwide Distribution - US Nationwide
Date initiated: 2017-08-02
Date posted: 2018-03-03
Date terminated: 2019-03-29
Location: Bedford, MA

Recalls and clearances share one API, with change alerts when new recalls post.

Record	Firm	Date
HEMOSIL READIPLAS TIN (K122584)	Instrumentation Laboratory CO	2013-03-24