Recall record at a glance
| Official record | Z-0635-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Helena Laboratories, Corp. |
| Report date | Dec 23, 2020 |
| Recall initiation date | Nov 9, 2020 |
| Quantity | Lot 1-19-K-ACT = 314 tubes and Lot 2-19-K-ACT = 297 tubes |
| Location | Beaumont, TX, United States |
Official 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.
Why the product was recalled
Due to complaints received associated with cracked/split test tube caps.
Distribution information
Worldwide distribution - U.S. Nationwide including in the states of NJ, NY, PA and TX. The countries of Austria, Canada, England, France, Italy, Portugal, Russia, Spain.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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