Z-1052-2022Class II

HemosIL ReadiPlasTin, Part No. 0020301400

Name: Z-1052-2022 HemosIL ReadiPlasTin, Part No. 0020301400
Creator: Instrumentation Laboratory
Published: 2022-04-08
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2022-04-08 / Open, Classified

FDA source

Instrumentation Laboratory began a recall of HemosIL ReadiPlasTin, Part No. 0020301400 on 2022-04-08. FDA classified it as Class II and gives the reason as "Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1052-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-08
Posted: 2022-05-10
Recalling firm: Instrumentation Laboratory Co.
Product: HemosIL ReadiPlasTin, Part No. 0020301400
Product code: GJS Test, Time, Prothrombin
Reason for recall: Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin 2G.
FDA root cause: Under Investigation by firm
Action: On April 8, 2022, the firm notified customers via email and certified mail. Customers were informed that the firm will stop shipment of product on May 9, 2022. After receipt of the material, customers must complete the conversion to HemosIL RecombiPlasTin 2G, with support as needed from your local Werfen representative, within 90 days. Until a lot of HemosIL RecombiPlasTin 2G has been received and ready for use, customers should run quality control for HemosIL ReadiPlasTin with each new reagent vial (every lot) and at least every 8 hours to identify vials with performance issues. Any product with failed quality control or quality control results which trend high should be discarded. Once customers have completed the comversion to HemosIL RecombiPlasTin 2G, any remaining unused HemosIL ReadiPlasTin should be destroyed.
Quantity in commerce: 1,563 (US); 29,046 (OUS)
Distribution: US Nationwide distribution including in the states of AZ, CA, IA, IL, IN, KS, MD, ME, MI, MN, MO, NC, NE, NY, OH, OK, SC, TX, VA, WV.
Product codes and lots: UDI 08426950632887 All in-date lots are affected by this recall.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1052-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1052-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-18	2022-05-10

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)