Devices

Device Recall Hemoglobin Test Kits

Model / Serial
Catholyte Solution Batch Lot #235867, included in kits labeled with Kit Lot Numbers: 234172, 234177, 234182, 234190, 234195, 234200, 234205, 234222, 234231, 234240, 234247, 234252, 234257, 234262, 234267, 234272, 234277, 238917, 238920 & 238923.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
The recalled kits were distributed to customers in the following locations: FL, OK, GA, MD, AZ, KY, NY, PR, OR, NJ, WA, MI, KS, AR, IN, TX, MN, CA, VA, NC, DE, UT, WI, SC, OH, MT, KS, CO & PR.
Product Description
RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro diagnostic use.
Manufacturer
PerkinElmer LAS Inc
1 Event
- Recall of Device Recall Hemoglobin Test Kits

Manufacturer

PerkinElmer LAS Inc

Manufacturer Address
PerkinElmer LAS Inc, 3985 Eastern Rd, Norton OH 44203-6215
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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