ACL TOP 300 Cts/350 Cts/500 Cts/550 Cts/970 Cl: Name recall
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…
Why was ACL TOP 300 Cts/350 Cts/500 Cts/550 Cts/970 Cl: Name recalled?
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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- 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…
- Recalling firm
- Instrumentation Laboratory
- Quantity
- 2725 units US: 5,572 units OUS.UPDATE: 2727 units US; 5277 units OUS
- Distribution
- 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.
- Recall date
- May 4, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)