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Lower risk Medical device recall · FDA · Published August 2, 2017

Hemosll ReadiPlasTin vials with performance issues recall

Instrumentation Laboratory Co. recalls Hemosll ReadiPlasTin vials (20ml) from specific lots due to increased imprecision and out of range quality controls.

🇺🇸 FDA recall #Z-0895-2018Medical deviceInstrumentation Laboratory Co. ›
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Recalling firmInstrumentation Laboratory Co.180 Hartwell Rd · Bedford, MA 01730-2443
✎ GovInfoNow plain-language explainer

What happened, in plain English

Instrumentation Laboratory Co. is recalling Hemosll ReadiPlasTin vials (20ml size) from certain lots because they may cause inaccurate test results. This affects users who rely on these vials for laboratory testing. Read more at govinfonow.com/recall/73263-hemosll-readiplastin-vials-with-performance-issues-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/73263-hemosll-readiplastin-vials-with-performance-issues-recall · Updated September 19, 2026 · FDA enforcement record: FDA #Z-0895-2018

Cite this page

“Hemosll ReadiPlasTin vials with performance issues recall.” GovInfoNow, updated September 19, 2026. https://govinfonow.com/recall/73263-hemosll-readiplastin-vials-with-performance-issues-recall. Based on FDA recall #Z-0895-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0895-2018%22&limit=1).

Why it’s dangerous

The recalled vials have been reported to show increased imprecision, out of range quality controls, and prolonged sample results. This means test results could be less accurate than expected.

Who’s affected

Laboratory users who purchased Hemosll ReadiPlasTin vials (20ml) from specific lots are affected. Those performing tests with these vials may experience inaccurate results.

How to tell if you have this one

Check the lot number on the vial. The affected lots are N1166235, N0177760, N0278358, N0478057, N0479504, and N0278177.

  • Brand
    Instrumentation Laboratory Co.
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Lot Number

    Identify the lot number on the vial to see if it matches the affected lots: N1166235, N0177760, N0278358, N0478057, N0479504, or N0278177.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide Distribution - US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

1. Firm started the recall: Aug 2, 201712. FDA classified it Class II: Mar 3, 201823. Published in FDA’s Enforcement Report: Mar 14, 201834. FDA terminated the recall: Mar 29, 2019420172019
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

What should I do if I have the recalled vial?

Check the lot number on the vial. If it matches the affected lots, you may need to stop using it and contact the manufacturer for further instructions.

Are there any safety risks from using these vials?

The recall is due to potential inaccurate test results, not immediate safety risks like injury or fire. The hazard is low risk.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0895-2018 (August 2, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0895-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA