Reported May 4, 2022 · Ongoing
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…
Instrumentation Laboratory
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Instrumentation Laboratory · 180 Hartwell Rd · Bedford, MA · 01730-2443
Is this the product you have?
- ACL TOP 300
- CTS/350 CTS/500 CTS/550 CTS/970 CLName 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
- Lot codes and dates
7 of 7 products
Products covered by this recall # Barcodes Product as published 1 08426950556916All Serial Numbers. Trade Name Part Number UDI ACL TOP 300 CTS 00000280060 08426950556916 2 08426950928027"ACL TOP 300 CTS (Refurbished)" 00000280060R 08426950928027 3 08426950784081ACL TOP 350 CTS 00000280065 08426950784081 4 08426950453499ACL TOP 500 CTS 00000280040 08426950453499 5 08426950928003"ACL TOP 500 CTS (Refurbished)" 00000280040R 08426950928003 6 08426950729242ACL TOP 550 CTS 00000280045 08426950729242 7 08430793045476ACL TOP 970 CL 00000280097 08430793045476. - Amount recalled
- 2725 units US: 5,572 units OUS.UPDATE: 2727 units US; 5277 units OUS
Where it was sold
- Nationwide
- PR
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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