Blood lead test kits recalled over mislabeled calibration buttons
Magellan Diagnostics is recalling 1,774 LeadCare II Blood Lead Test Kits because calibration buttons used in kitting were labelled with the wrong lot number.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states mislabelled calibration buttons can produce erroneously high or low lead results, and no injuries are reported.
Plain-English summary
The LeadCare II Blood Lead Test Kit, catalog number 70-6762, is being recalled. The LeadCare II Blood Lead Test System relies on electrochemistry and a sensor to detect lead in whole blood, and the kit is supplied with sensors, treatment reagent and other materials.
Calibration Buttons used in the kitting process were incorrectly labelled as Lot 2323M for lot 2333M. Magellan states the use of a mislabelled calibration button with lot 2333 can lead to delayed, erroneously high or erroneously low results.
The recall covers 1,774 units across impacted lot and sublot numbers including 2333M. The product was distributed nationwide in the United States. The FDA has classified the action as Class II.
Blood lead testing is used heavily in paediatric screening, so a wrong result in either direction matters. Laboratories holding affected kits should follow Magellan's instructions.
The recalled product
- Product
- The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The LeadCare¿ II Test Kit is provided with the following materials: " Sensors (2 Containers of 24 sensors each; 48 tests) " Treatment Reagent Tubes (2…
- Manufacturer
- Magellan Diagnostics, Inc.
- Category
- Medical Device — Diagnostic test
- Affected units
- 1,774
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- Product Name: LeadCare¿ II Blood Lead Test Kit
- Catalog Number: 70-6762
- Impacted Lot/Sublot Numbers: 2333M
- 2333M-01
- 2333M-02
- 2333M-03
- 2333M-04
- 2333M-05
- 2333M-06
- 2333M-07
- 2333M-08
- 2333M-09
- 2333M-10
- 2333M-11
- Device Identifier: (01)00850355006000
Distribution
Distributed nationwide across the United States.
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