Device recall: Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
Class I FDA enforcement event 76991. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Magellan Diagnostics, Inc. started this device recall on 29 Nov 2014. The firm address in the FDA record is in North Billerica, MA. FDA put the recall in Class I. FDA event 76991 has 2 product records. The first FDA enforcement report date is 24 May 2017. The record gives the status Terminated, with the termination date 26 Feb 2022.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide Distribution
Recalling firm
Magellan Diagnostics, Inc., North Billerica, MA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1925-2017 | Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010 | 49 units | Class I | Terminated | 24 May 2017 |
| Z-1926-2017 | Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010 | 1016 | Class I | Terminated | 24 May 2017 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2014
- 1,176
- Share of these events in Class I
- 5%
- Product records in this event
- 2Median of the firm: 2
- Events of the firm on the register
- 9
Other events of the firm
Official channels
- FDA enforcement report Z-1925-2017The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 76991. https://recallregister.com/fda/i/76991/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide Distribution
- What quantity of product is in FDA event 76991?
- The event has 2 product records. The first record gives this quantity:
49 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2014 have the same class?
- 5% of the 1,176 device events that started in 2014 are in Class I.