[Recalled] ACL TOP 700; PN 0000280010 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessmen
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | ACL TOP 700; PN 0000280010 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both |
|---|---|
| Brand / manufacturer | Instrumentation Laboratory Co. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2245-2013 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 19 July 2013 |
| EAN / barcode | 09080100 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.