Instrumentation Laboratory Recalls ACL TOP Coagulation Instruments
Instrumentation Laboratory Co. is recalling 1,074 ACL TOP (Base) automated coagulation laboratory instruments due to a potential for sample misidentification.
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: The recall is classified as FDA Class II, and the hazard of sample misidentification in a laboratory instrument poses a risk of harm where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Instrumentation Laboratory Co. is recalling 1,074 units of the ACL TOP (Base) automated coagulation laboratory instrument. The recall is being conducted because of a potential for sample misidentification.
The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries. The serial numbers for the recalled units range from 03110101 (November 2003) to 11111174 (November 2011).
Healthcare facilities and laboratories should contact Instrumentation Laboratory Co. for instructions on how to manage the recalled devices.
The recalled product
- Product
- ACL TOP (Base), automated coagulation laboratory instrument.
- Manufacturer
- Instrumentation Laboratory Co.
- Hazard
- Affected units
- 1,074
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: 03110101 Nov 2003 and End SN and Date 11111174 Nov 2011
Distribution
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.
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