CLASS III ONGOING Device recall · Reported 21 Oct 2026 · FDA Enforcement Report
LeadCare II Blood Lead Test Kit recalled by Magellan Diagnostics
Magellan Diagnostics is recalling LeadCare II Blood Lead Test Kit, distributed nationwide in the US. The recall was initiated on 4 Sep 2026 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0162-2027
- FDA event ID
- 99776
- Recalling firm
- Magellan Diagnostics, North Billerica, MA
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 4 Sep 2026
- FDA classified
- 15 Oct 2026
- Reported
- 21 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 4 Sep 2026 | Recall initiated by company | |
| 15 Oct 2026 | Classified by FDA | +41 days |
| 21 Oct 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026. If used the system will display an error message and prevent the operator from running the test. Resulting in delayed results.
Product as listed by the FDA
LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.
Where it was distributed
US Nationwide distribution in the states of CA, IN, PA, TX, NE, IL, MA, MO, KY.
Nationwide CaliforniaIllinoisIndianaKentuckyMassachusettsMissouriNebraskaPennsylvaniaTexas
Questions about this recall
Why was it recalled?
In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026. If used the system will display an error message and prevent the operator from running the test. Resulting in delayed results.
Which lots are affected?
Model/Catalog Number: 70-6762. UD-DI: 00850355006000. Lot Number. 2530M-01.
Where was it sold?
US Nationwide distribution in the states of CA, IN, PA, TX, NE, IL, MA, MO, KY.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 27 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Magellan Diagnostics
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | LeadCare Ultra Blood Lead Test Kit recalled by Magellan Diagnostics | Magellan Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | (2) LeadCare¿ II Blood Lead Test Kit recalled by Magellan Diagnostics | Magellan Diagnostics | Packaging Defects | Nationwide |
| Device | CLASS II | LeadCare¿ Plus Blood Lead Test Kit recalled by Magellan Diagnostics | Magellan Diagnostics | Packaging Defects | Nationwide |
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