Recall Z-0635-2021— Helena Laboratories, Corp.
Class II · Ongoing
Class II FDA medical device recall by Helena Laboratories, Corp., initiated 2020-11-09. It names 2 FDA 510(k) clearances: K061014, K013078. Product: K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM.. Reason: Due to complaints received associated with cracked/split test tube caps..
- Recalling firm
- Helena Laboratories, Corp.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-11-09
- Firm location
- Beaumont, TX, United States
510(k) clearances named in this recall
2 on FDA's record- K061014 — ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
- K013078 — ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752
K-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
K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM.
Reason for recall
Due to complaints received associated with cracked/split test tube caps.
Data sourced from openFDA. This site is unofficial and independent of the FDA.