Z-0077-2019Class II

Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL ReadiPlasTin is an in...

Name: Z-0077-2019 Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL ReadiPlasTin is an in...
Creator: Instrumentation Laboratory Co.
Published: 2018-08-01
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2018-08-01 / Terminated / root cause: manufacturing process

FDA source

Instrumentation Laboratory Co. began a recall of Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on... on 2018-08-01. FDA classified it as Class II and gives the reason as "There is a potential for increased imprecision, out of range quality controls and prolonged sample results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0077-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-01
Posted: 2018-10-05
Terminated: 2019-04-16
Recalling firm: Instrumentation Laboratory Co.
Product: 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.
Product code: GJS Test, Time, Prothrombin
Reason for recall: There is a potential for increased imprecision, out of range quality controls and prolonged sample results.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: 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 [email protected]. - 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.
Quantity in commerce: 9751 kits
Distribution: US Nationwide
Product codes and lots: Lot Number - N0278177 Exp. Date February 28, 2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0077-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0077-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-17	2018-10-05

Product code GJS

K122584Class IIHemosil Readiplas TinInstrumentation Laboratory CO / cleared 2013-03-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)