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ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060...

FDA Device Recall #Z-1014-2022 — Class II — February 22, 2022

Recall Summary

Recall Number Z-1014-2022
Classification Class II — Moderate risk
Date Initiated February 22, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Instrumentation Laboratory
Location Bedford, MA
Product Type Devices
Quantity 2725 units US: 5,572 units OUS.UPDATE: 2727 units US; 5277 units OUS

Product Description

ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS 00000280060R (Refurbished) 3. ACL TOP 350 CTS 00000280065 4. ACL TOP 500 CTS 00000280040 5. ACL TOP 500 CTS 00000280040R ( Refurbished) 6/ 6. ACL TOP 550 CTS 00000280045 7. ACL TOP 970 CL 00000280097

Reason for Recall

Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or rivaroxaban when HemosIL Liquid Anti-Xa reagent is used in the same run with both HemosIL Liquid Antithrombin and HemosIL Q.F.A. Thrombin (Bovine), specific to instrument models that utilize a single reagent probe

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belarus, Belgium, Bermuda, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Ecuador, El Salvador, France, Germany, Gibraltar, Great Britain, Greece, Guatemala, Guyana, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kosovo, Kuwait, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, S. Tome, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Tanzania, Thailand, Trinidad, Tobago, Tunisia, Turkey, United Arab Emirates, Uruguay, Venezuela, Vietnam.

Lot / Code Information

All Serial Numbers. Trade Name Part Number UDI ACL TOP 300 CTS 00000280060 08426950556916; "ACL TOP 300 CTS (Refurbished)" 00000280060R 08426950928027; ACL TOP 350 CTS 00000280065 08426950784081; ACL TOP 500 CTS 00000280040 08426950453499; "ACL TOP 500 CTS (Refurbished)" 00000280040R 08426950928003; ACL TOP 550 CTS 00000280045 08426950729242; ACL TOP 970 CL 00000280097 08430793045476.

Other Recalls from Instrumentation Laboratory

Recall # Classification Product Date
Z-1538-2026 Class II GEM Premier 5000; Part No. 00055430008. Jan 20, 2026
Z-1528-2026 Class II GEM Premier 5000 PAK; Part No. 00055407504. Jan 20, 2026
Z-1524-2026 Class II GEM Premier 5000 PAK, Part No. 00055360004. Jan 20, 2026
Z-1533-2026 Class II GEM Premier 5000; Part No. 00055415005. Jan 20, 2026
Z-1534-2026 Class II GEM Premier 5000; Part No. 00055415008. Jan 20, 2026

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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