Instrumentation Laboratory ACL TOP 700 CTS Analyzer Recall for Carryover Issue
Instrumentation Laboratory is recalling 185 ACL TOP 700 CTS analyzers due to a potential carryover issue that may cause shortened APTT clotting times.
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 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 185 units of the ACL TOP 700 CTS bench-top analyzer. The recall is due to a potential carryover issue that can cause shortened APTT clotting times on the instrument. The affected devices are fully automated, random access analyzers designed for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing.
The recall covers units with serial numbers ranging from 09120101 (December 2009) to 13070304 (July 2013). The devices were distributed worldwide, including in the United States and numerous international locations. The agency has classified this recall as Class II.
Consumers and healthcare facilities should contact Instrumentation Laboratory Co. for instructions on how to address the issue. The recall is intended to prevent potential inaccuracies in coagulation testing results.
The recalled product
- Product
- ACL TOP 700 CTS; PN 0000280050 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 hemostasis. The systems…
- Manufacturer
- Instrumentation Laboratory Co.
- Hazard
- Affected units
- 185
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 (4)
- Start SN and Date: 09120101
- Dec 2009
- End SN and Date: 13070304
- July 2013
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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