Medical Device Recall: Z-0077-2019

FDA Recalls dataset · Firm: Instrumentation Laboratory Co. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2018-08-01 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0077-2019.

Recall Res Number
Z-0077-2019
Recalling Firm / Manufacturer
Instrumentation Laboratory Co.
FEI Number
1217183
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2018-08-01
Date Posted
N/A
Date Terminated
2019-04-16
Product Code
GJS
Event Number
80932
Product Quantity
9751 kits
Product Description Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.
Reason for Recall There is a potential for increased imprecision, out of range quality controls and prolonged sample results.
Action Details On August 1, 2018, Instrumentation Laboratory issued Urgent Medical Device Removal and Field Safety notices to their customers. Customers were advised to take the following actions: - Run quality controls with each vial and a minimum of every 8 hours per labeled insert instructions to identify possible vials with the above performance issues until an alternative product lot of HemosIL ReadiPlasTin or an alternative PT reagent has been received and is ready for use. NOTE: ACL TOP Family and ACL TOP Family 50 Series analyzers can be configured to automatically perform QC at vial change. Reference "Before vial use" under the QC Setup Definition section of the On-line Help or contact your IL representative for assistance. - Discard any vial with failed quality controls. Only use vials where all quality controls are in range. - Check your inventory for Lot No. N0278177 and add instructions (copy of the notice) to run quality controls with each vial. - Contact your local representative to convert to an alternative product lot of HemosIL ReadiPlasTin or an alternative PT reagent. - Verify the alternative lot immediately on receipt and then destroy any unused boxes of Lot No. N0278177. - Document the destruction on the Mandatory Tracking Response Record and return the completed and signed form to IL Regulatory either via fax to 781-861-4207 or via email to ra-usa@ilww.com. - Share the information with all laboratory staff and follow your internal procedures. - Forward the notification to all affected locations within your facility. - Retain a copy of the notification for your records.
Distribution Pattern US Nationwide
Code Information / Serial Numbers Lot Number - N0278177 Exp. Date February 28, 2019

Related Establishments / Registrations

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