Reported Sep 20, 2023 · Ongoing
ACL TOP Family 50 Series Models as follows
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 Family 50 Series Models as follows
5 of 5 products
| Model / number | Product as published |
|---|---|
00000280045 | In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis (1) ACL TOP 550 CTS |
00000280055 | (2) ACL TOP 750 CTS |
00000280065 | (3) ACL TOP 350 CTS |
00000280015 | (4) ACL TOP 750 |
00000280097 | (5) ACL TOP 750 LAS Model Number: 00000280035 (6) ACL TOP 970 CL(only available ROW) |
- Lot codes and dates
14 of 14 products
Products covered by this recall # Barcodes Product as published 1 08426950729242Model Names UDI (1)ACL TOP 550 CTS 08426950729242 2 08426950784067(2)ACL TOP 750 CTS 08426950784067 3 08426950784081(3)ACL TOP 350 CTS 08426950784081 4 08426950784074(4) ACL TOP 750 08426950784074 5 0842695078405008430793045476(5) ACL TOP 750 LAS 08426950784050 (6) ACL TOP 970 CL 08430793045476 Software: 1)ACL TOP 550 CTS v6.3.0 or later 6 (2)ACL TOP 750 CTS v6.3.0 or later 7 (3)ACL TOP 350 CTS v6.3.0 or later 8 (4) ACL TOP 750 v6.3.0 or later 9 (5) ACL TOP 750 LAS v6.3.0 or later 10 (6) ACL TOP 970 CL Version 1.1.0 (OUS). UPDATE: 10/16/23 Affected Serial Number Range Start SN End SN ACL TOP 350 CTS 21113058 23074369 11 ACL TOP 550 CTS 21112046 23072623 12 ACL TOP 750 22010516 23060671 13 ACL TOP 750 CTS 21110860 23071015 14 ACL TOP 750 LAS 21120879 23071077 - Amount recalled
- 2,068 kits US: 6,270 units OUS
Where it was sold
- Nationwide
Why it was recalled
Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result
This product could cause temporary or reversible health problems — stop using it.
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