Instrumentation Laboratory ACL TOP 300 Analyzers Recalled for Carryover Issue
Instrumentation Laboratory is recalling 662 ACL TOP 300 and ACL TOP 300 CTS analyzers worldwide due to a potential carryover issue that may cause shortened APTT clotting times.
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 and 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 662 units of the ACL TOP 300 and ACL TOP 300 CTS bench top, fully automated, random access analyzers. These devices are designed for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing. The affected units were distributed worldwide, including in the United States and numerous international locations.
The recall is due to a potential carryover issue on the instrument that can cause shortened APTT clotting times. The affected serial numbers range from 12060256 to 13070837 (manufactured June 2012 to July 2013) and from 11120131J to 13060320J (manufactured December 2011 to June 2013). The agency has classified this as a Class II recall.
Healthcare facilities and laboratories using these devices should contact Instrumentation Laboratory Co. for instructions on how to address the issue. The source text does not specify specific consumer actions beyond the recall notification.
The recalled product
- Product
- ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or
- Manufacturer
- Instrumentation Laboratory Co.
- Hazard
- Affected units
- 662
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 (7)
- Start SN and Date: 12060256
- Jun 2012
- End SN and Date: 13070837
- July 2013 and Start SN and Date: 11120131J
- Dec 2011
- End SN and Date: 13060320J
- Jun2013
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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