The Recall Desk
HighFDA (Devices)·Z-2064-2014·Announced 2014-07-23

Instrumentation Laboratory Recalls ACL TOP 500 CTS Coagulation Instruments

Instrumentation Laboratory is recalling ACL TOP 500 CTS automated coagulation laboratory instruments due to a potential for sample misidentification.

What this means for you

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: The recall is classified as FDA Class II. The hazard involves potential sample misidentification in a medical device, which poses a risk of harm, but the source text does not report specific injuries or illnesses, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Instrumentation Laboratory Co. is recalling 2,802 units of the ACL TOP 500 CTS automated coagulation laboratory instrument. The recall was initiated because of a potential for sample misidentification.

The affected units were distributed worldwide, including nationwide in the United States and in numerous countries across North America, South America, Europe, Asia, Africa, and Oceania. The serial numbers for the recalled units range from 08010100 (January 2008) to 14052901 (May 2014).

Healthcare facilities and laboratories should contact Instrumentation Laboratory Co. for instructions on how to handle the recalled devices.

The recalled product

Product
ACL TOP 500 CTS, automated coagulation laboratory instrument.
Manufacturer
Instrumentation Laboratory Co.
Category
Medical Device — Laboratory Instrument
Hazard
Affected units
2,802

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)

  • Start SN and Date: 08010100 Jan 2008 End SN and Date 14052901 May 2014

Distribution

Distributed nationwide across the United States.

The notice also names 47 states specifically:

Part of a larger recall action

This product is one of 7 recalled by Instrumentation Laboratory Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Related recalls

Same manufacturer · Instrumentation Laboratory Co.

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Same hazard · sample misidentification

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