Instrumentation Laboratory Recalls ACL TOP 700 LAS Coagulation Instruments
Instrumentation Laboratory is recalling 99 ACL TOP 700 LAS 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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Instrumentation Laboratory Co. is recalling 99 units of the ACL TOP 700 LAS, an automated coagulation laboratory instrument. The recall is due to a potential for sample misidentification.
The affected units were distributed nationwide in the United States and internationally to numerous countries including Canada, Mexico, and various nations in Europe, Asia, and South America. The serial numbers for the recalled units range from 08120100 (December 2008) to 14050198 (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 700 LAS, automated coagulation laboratory instrument.
- Manufacturer
- Instrumentation Laboratory Co.
- Hazard
- Affected units
- 99
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: 08120100 Dec 2008 End SN and Date 14050198 May 2014
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.
See all 7 products in this recall →Related recalls
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Similar recalls
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