Z-0276-2022Class II

HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent

Name: Z-0276-2022 HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent
Creator: Instrumentation Laboratory
Published: 2021-10-13
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2021-10-13 / Open, Classified

FDA source

Instrumentation Laboratory began a recall of HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent on 2021-10-13. FDA classified it as Class II and gives the reason as "The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0276-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-10-13
Posted: 2021-11-23
Recalling firm: Instrumentation Laboratory Co.
Product: HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
Product code: GJS Test, Time, Prothrombin
Reason for recall: The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or do not pass for each vial of reagent, there is a potential risk of reporting an erroneous result.
FDA root cause: Under Investigation by firm
Action: On October 13, 2021, the firm sent customers Urgent Medical Device Removal letters via email. These emails were followed by certified letters sent starting the same day. ***On February 17, 2022, the firm expanded the recall to include an additional lot of product.*** The customers were provided with instructions to run quality controls with each vial. Customers should discard any vials with failed quality controls. For technical questions, please contact the IL Technical Support Center at 1-800-678-0710, Option # 2 (ACL Coagulation Products). For alternate lot availability questions, please contact your IL Customer Service Representative at 1-800-955-9525, Option # 0.
Quantity in commerce: 5828 kits (310 US)
Distribution: Worldwide distribution - US Nationwide distribution in the states of AZ, CA, IA, IL, KS, ME, MI, NC, NY, OK, SC, and VA. The countries of Canada, Chile, China, Costa Rica, Italy, Japan, and South Korea. ***Updated 3/3/22*** Expansion includes states of IN, MN, and NC.
Product codes and lots: Lot N0705526 UDI: 08426950632887 ***Updated 3/3/22*** Firm has expanded recall to include the following lot: N0806224

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0276-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0276-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-01	2021-11-24

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)