Recall Z-2578-2023— Instrumentation Laboratory
Class II · Ongoing
Class II FDA medical device recall by Instrumentation Laboratory, initiated 2023-07-13. It names one FDA 510(k) clearance: K150877. Product: ACL TOP Family 50 Series Models as follows: 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 Model Number: 00000280045; (2) ACL TOP 750 CTS Model Number: 00000280055; (3) ACL TOP 350 CTS Model Number: 00000280065; (4) ACL TOP 750 Model Number: 00000280015; (5) ACL TOP 750 LAS Model Number: 00000280035 (6) ACL TOP 970 CL(only available ROW)Model Number: 00000280097. Reason: Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result.
- Recalling firm
- Instrumentation Laboratory
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-07-13
- Firm location
- Bedford, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ACL TOP Family 50 Series Models as follows: 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 Model Number: 00000280045; (2) ACL TOP 750 CTS Model Number: 00000280055; (3) ACL TOP 350 CTS Model Number: 00000280065; (4) ACL TOP 750 Model Number: 00000280015; (5) ACL TOP 750 LAS Model Number: 00000280035 (6) ACL TOP 970 CL(only available ROW)Model Number: 00000280097
Reason for recall
Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result
Data sourced from openFDA. This site is unofficial and independent of the FDA.