Z-0895-2018Class II

Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400

Name: Z-0895-2018 Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
Creator: Instrumentation Laboratory Co.
Published: 2017-08-02
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2017-08-02 / Terminated

FDA source

Instrumentation Laboratory Co. began a recall of Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400 on 2017-08-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0895-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-02
Posted: 2018-03-03
Terminated: 2019-03-29
Recalling firm: Instrumentation Laboratory Co.
Product: Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
Product code: GJS Test, Time, Prothrombin
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.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 14,894 kits
Distribution: Worldwide Distribution - US Nationwide
Product codes and lots: Lots: N1166235, N0177760, N0278358, N0478057, N0479504 & N0278177.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0895-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0895-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-03

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)