Instrumentation Laboratory Recalls Hemosll ReadiPlasTin Kits Due to Performance Issues
Instrumentation Laboratory is recalling 14,894 Hemosll ReadiPlasTin kits due to reported performance issues, including increased imprecision and out-of-range quality controls.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states no illnesses or injuries were reported, and the hazard is limited to performance issues (imprecision, out-of-range controls) rather than direct physical harm, fitting the 'voluntary precautionary' or 'low-risk' criteria for a Moderate score.
Plain-English summary
Instrumentation Laboratory Co. is recalling 14,894 units of Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400. The affected lots are N1166235, N0177760, N0278358, N0478057, N0479504, and N0278177. The product was distributed worldwide and nationwide in the United States.
The recall was initiated after the company received customer reports of performance issues with some vials from Lot Nos. N1166235 and N0177760. These issues included increased imprecision, out-of-range quality controls, and prolonged sample results. The source text does not report any illnesses or injuries associated with the use of these devices.
Healthcare facilities and users should stop using the affected lots and contact Instrumentation Laboratory Co. for further instructions or a refund. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
- Manufacturer
- Instrumentation Laboratory Co.
- Affected units
- 14,894
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lots: N1166235
- N0177760
- N0278358
- N0478057
- N0479504 & N0278177.
Distribution
Distributed nationwide across the United States.
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