Reported Aug 23, 2017 · Terminated
LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of…
Magellan Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Magellan Diagnostics, Inc. · 101 Billerica Ave Bldg 4 · North Billerica, MA · 01862-1271
Is this the product you have?
- LeadCare II Blood Lead Test Kit, containing
- LeadCare II Lead Controls Product UsageIVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinized capillary tubes and plungers, transfer droppers and a calibration button. The LeadCare II Lead Controls packaged in the kit lots listed in #2 below are the subject of this recall (Field Correction) action
- Lot codes and dates
- Lot # :1507N
- Exp Date
1/27/17Lot # :1508N
- Exp Date
2/27/17Lot # :1510N
- Exp Date
4/19/17Lot # :1511M
- Exp Date5/3/17 Lot # :1511N
- Exp Date5/17/17 Lot # :1512M
- Exp Date6/2/17
- Amount recalled
- 12,931 kits
Where it was sold
- Nationwide
Why it was recalled
LeadCare II Test Kits controls out of range
This product could cause temporary or reversible health problems — stop using it.
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