Recall record at a glance
| Official record | Z-2251-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Abbott Laboratories |
| Report date | Jun 10, 2020 |
| Recall initiation date | Apr 2, 2020 |
| Quantity | 11 |
| Location | Irving, TX, United States |
Official product description
Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a modular system designed to automate sample handling and processing in the clinical laboratory. The system allows consolidations of multiple clinical chemistry and immunoassay analytical instruments into a unified workstation.
Why the product was recalled
In the case of an AQM clot detection error a portion of the distilled water from the Aliquoter Module hydraulic circuit may be dispensed into the Primary Tube leading to sample dilution, which could lead to incorrect results.
Distribution information
Worldwide distribution - U.S. Nationwide distribution including in the states of NC, ND, SC, TN. The countries of United Kingdom, France, New Zealand, Pakistan, Turkey.
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: Letter.
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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