Information on the LeadCare® II Test Kit "Treatment Reagent Cap" Field Action
Magellan Diagnostics is alerting customers & distributors to a field action notification regarding multiple LeadCare® II Test kit lots.
Magellan identified an issue with the Treatment Reagent tubes included in certain LeadCare II Blood Lead Test Kits (Catalog #70-6762). Certain sublots of LeadCare II Test Kits impacted by this field action are shown in the table below.
Please note you may continue to use any impacted product. Magellan will replace any unexpired, impacted test kits upon request.
The plastic caps used to close the treatment reagent tubes undergo dimension testing prior to production. A small percentage of these caps did not meet internal specifications and could result in leaking of the treatment reagent.
As the issue has the potential to change the volume of the treatment reagent, test results could be falsely elevated (PATFP) or can produce a control out-of-range – high (COOR-Hi). Out of an abundance of caution, Magellan has initiated this field action to notify customers of the current situation.
Please review the test kit LOT numbers below that are impacted by this field action. The lot number can be located on the outside of the test kit box:
| Product Name: | LeadCare® II Blood Lead Test Kit | ||||
| Catalog Number: | 70-6762 | ||||
| UDI | (01)00850355006000 | ||||
| Affected Sublot Numbers | 2231M | 2306M-05 | 2310M-03 | 2313M | 2315M-07 |
| 2231M-10 | 2306M-06 | 2310M-04 | 2313M-01 | 2315M-08 | |
| 2303M-11 | 2307M | 2310M-05 | 2313M-05 | 2315M-13 | |
| 2303M-12 | 2307M-04 | 2310M-06 | 2313M-07 | 2316M | |
| 2303M-13 | 2307M-05 | 2310M-08 | 2314M-06 | 2316M-03 | |
| 2303M-15 | 2307M-06 | 2311M-02 | 2314M-07 | 2316M-04 | |
| 2305M-01 | 2307M-07 | 2311M-03 | 2314M-08 | 2316M-05 | |
| 2305M-02 | 2307M-10 | 2311M-05 | 2314M-09 | 2316M-06 | |
| 2305M-03 | 2307M-11 | 2311M-09 | 2314M-12 | 2316M-11 | |
| 2305M-04 | 2308M-01 | 2311M-10 | 2314M-13 | 2316M-12 | |
| 2305M-05 | 2308M-02 | 2312M | 2315M-02 | 2317M | |
| 2306M-01 | 2308M-03 | 2312M-01 | 2315M-03 | 2317M-01 | |
| 2306M-02 | 2308M-07 | 2312M-04 | 2315M-04 | 2318M | |
| 2306M-03 | 2309M | 2312M-05 | 2315M-05 | 2320M-06 | |
| 2306M-04 | 2310M-01 | 2312M-07 | 2315M-06 | 7308M | |
| Magellan Reference No. | 1218996-09/06/2023-0001R | ||||
To download a copy of the Field Action Notification,
please complete the form below:
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FAQs
If I received an impacted test kit, what do I need to do?
FDA requires the field action notification form to be completed and returned to Magellan Diagnostics as directed. Please complete the field action notification form even if you have no remaining inventory in stock.
When were these lots distributed?
The impacted LeadCare test kits were distributed between April 8, 2022, and August 31, 2023.
Can I continue using LeadCare test kits?
Yes, you may continue to use any impacted test kits for testing patients as usual.
Does this impact LeadCare instruments?
LeadCare Analyzers ARE NOT impacted by this field action. You are still able to use all instrumentation.
Do I need to evaluate the results that were previously reported?
No. You are not required to review previously elevated results. However, your office/ laboratory should follow your own policies and procedures or those of applicable local, state, or accrediting agencies regarding patient results.
Will you be sending replacement test kits?
You may continue to use any impacted test kits that fall under this field notification. However, Magellan will replace any remaining unexpired stock upon request.
Are you accepting new purchase orders at this time?
Yes, we are still accepting new purchase orders currently. Please note new kit orders may take longer than average for delivery due to the backlog of open orders. We will work diligently to ship your new LeadCare kits as quickly as possible.
