Recall record at a glance
| Official record | Z-1295-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Magellan Diagnostics, Inc. |
| Report date | Apr 11, 2018 |
| Recall initiation date | Jan 9, 2018 |
| Quantity | 6,143 |
| Location | North Billerica, MA, United States |
Official product description
LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only.
Why the product was recalled
The incorrect placement of AA batteries into certain LeadCare II Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the batteries are removed while hot.
Distribution information
Worldwide Distribution
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.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.