Clotting time test cuvettes recalled over a sharp-edged foreign object
Accriva Diagnostics is recalling 20,250 Hemochron Activated Clotting Time Low-Range test cuvettes because a foreign object with sharp edges may pose a risk of injury if not detected before handling.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states a sharp-edged foreign object could pose a risk of injury to the handler, and no injuries are reported.
Plain-English summary
The Hemochron Activated Clotting Time Low-Range Test Cuvette, REF ACT-LR, used with the Hemochron Signature ELITE Whole Blood Microcoagulation System, is being recalled by Accriva Diagnostics.
The test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.
The record lists 20,250 units carrying UDI-DI 10711234103081, from lot E5JLR132 with an expiration of 08-31-2026. Distribution was worldwide, including nationwide in the United States across Ohio, Illinois, New York, Georgia, California, Indiana, New Jersey, Texas, Kansas, Nebraska and Florida among other states. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Laboratories should quarantine the affected lot and follow Accriva's instructions.
The recalled product
- Product
- Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
- Manufacturer
- Accriva Diagnostics, Inc.
- Affected units
- 20,250
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 (1)
- UDI-DI: 10711234103081. Lot: E5JLR132. Expiration: 08-31-2026
Distribution
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